Immunotherapy Combinations for Non-Small Cell Lung Cancer

(Morpheus Lung Trial)

Not currently recruiting at 51 trial locations

Overseen By Reference Study ID Number: BO39610 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Hoffmann-La Roche

Disqualifiers: Autoimmune disease, CNS metastases, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new combinations of immunotherapy drugs for treating non-small cell lung cancer (NSCLC) that has metastasized. The goal is to determine the safety and effectiveness of these drug combinations. Individuals with newly diagnosed NSCLC or those whose condition has worsened despite previous treatments may qualify for this study. Participants will try different drug combinations and can switch treatments if the cancer progresses or side effects become too severe. As a Phase 1/Phase 2 trial, this study aims to understand how the treatment works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of atezolizumab with bevacizumab and camonsertib is generally well-tolerated. In previous studies, about 27.7% of patients experienced immune-related side effects, with serious side effects occurring in around 9.9%. This indicates the treatment is mostly safe, though some people may have side effects.

For the atezolizumab, bevacizumab, and tiragolumab combination, studies have found no new safety concerns. The side effects were similar to those already known for these drugs, meaning they are expected and manageable.

The combination of atezolizumab with cobimetinib was found to be tolerable, meaning patients could handle the treatment without severe issues. The side effects were what doctors expected from these drugs.

Atezolizumab combined with RO6958688 has been tested in multiple studies, showing it can be used safely. Some patients experienced mild immune-related effects.

The atezolizumab, pemetrexed, and carboplatin combination did not result in any treatment-related deaths in studies, suggesting it is relatively safe. The side effects were typical for this type of cancer treatment.

The combination of atezolizumab, gemcitabine, and carboplatin has been evaluated before, and while it does have side effects, they are generally manageable, suggesting the treatment is mostly safe.

The atezolizumab and ipatasertib mix has shown good safety results. In studies, the side effects were what doctors expected, indicating this treatment is safe for many patients.

The atezolizumab and linagliptin combination has undergone safety reviews, showing a 50% rate of serious side effects in some studies. While these numbers are notable, the treatment is still considered manageable.

Atezolizumab combined with CPI-444 did not show any new safety concerns in studies. This means the side effects were consistent with what doctors already know, making the treatment generally safe.

Atezolizumab with sacituzumab govitecan has been tested, and while there are side effects, they are known and expected. This suggests the treatment is safe for most patients.

Finally, the combination of atezolizumab, tiragolumab, and XL092 (zanzalintinib) did not have any major new safety issues in studies. The side effects were consistent with what is known for these treatments.

In summary, all these combinations have been studied for safety, and while each has its side effects, they are generally manageable. This means the treatments are mostly safe for patients, with expected side effects that doctors can handle. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for non-small cell lung cancer because they combine immunotherapy with targeted therapies, offering potentially enhanced effectiveness. Atezolizumab, used in various combinations, is an immune checkpoint inhibitor that helps the immune system attack cancer cells more effectively. Some combinations, like Atezolizumab with Bevacizumab and Camonsertib or Tiragolumab, leverage multiple mechanisms to inhibit tumor growth and enhance immune response. Others, such as Atezolizumab with Cobimetinib or RO6958688, target specific pathways involved in cancer cell survival and proliferation. These combinations aim to tackle the cancer from multiple angles, which could improve outcomes compared to standard treatments like chemotherapy alone.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial explores various combinations of atezolizumab to enhance treatment effectiveness for non-small cell lung cancer (NSCLC). Participants in different trial arms will receive distinct combinations. Atezolizumab, which previous studies have shown to improve survival rates and be generally safe, is combined with bevacizumab and camonsertib in one arm, effectively treating advanced NSCLC. Another arm pairs atezolizumab with tiragolumab, which has shown mixed results in past research but remains promising due to its unique immune system effects. The combination of atezolizumab and cobimetinib, tested in another arm, has slowed cancer progression in some patients. Additionally, atezolizumab with RO6958688 is under study, as earlier data indicate that atezolizumab alone improves survival in advanced NSCLC. These combinations are part of the trial's efforts to find more effective NSCLC treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with metastatic non-small cell lung cancer. Cohort 1 includes those who haven't had systemic therapy and have high PD-L1 in tumors. Cohort 2 has patients whose disease progressed after platinum-based and PD-L1/PD-1 inhibitor treatments. Participants must be able to perform daily activities with minimal assistance, have a life expectancy of at least 3 months, measurable disease, proper organ function, and agree to use contraception.

Inclusion Criteria

My blood and organs are functioning well.

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm

My lung cancer is confirmed to be non-small cell type and has spread.

Exclusion Criteria

I have a history of certain lung conditions or signs of lung inflammation on a chest scan.

I frequently need procedures to remove excess fluid from my body.

I have brain metastases that are untreated or getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants receive various immunotherapy-based treatment combinations until unacceptable toxicity or loss of clinical benefit

Variable (cycle length 21-28 days)

Treatment Stage 2

Participants who experience disease progression or loss of clinical benefit in Stage 1 may continue treatment with a different regimen

Variable (cycle length 21 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Carboplatin
• Pemetrexed
• Radiation

Trial Overview The study tests various immunotherapy combinations on two groups: one untreated for metastatic NSCLC (high tumor PD-L1 expression), the other previously treated but progressed. It assesses effectiveness, safety, and drug behavior in the body over two stages—initial treatment followed by an alternative if needed due to progression or side effects.

How Is the Trial Designed?

Group I: Stage 2: Cohort 2: Atezolizumab + RO6958688 Experimental Treatment 3 Interventions

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group II: Stage 2: Cohort 2: Atezolizumab + Linagliptin Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group III: Stage 2: Cohort 2: Atezolizumab + Docetaxel Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who have received treatment with Atezolizumab + Docetaxel in Stage 1 will not receive this treatment in Stage 2.

Group IV: Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin Experimental Treatment 3 Interventions

Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group V: Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin Experimental Treatment 3 Interventions

Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group VI: Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group VII: Stage 1: Cohort 2: Atezolizumab + RO6958688 Experimental Treatment 3 Interventions

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group VIII: Stage 1: Cohort 2: Atezolizumab + Ipatasertib Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Ipatasertib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group IX: Stage 1: Cohort 2: Atezolizumab + Evolocumab Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Group X: Stage 1: Cohort 2: Atezolizumab + Docetaxel Experimental Treatment 2 Interventions

Participants in Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group XI: Stage 1: Cohort 2: Atezolizumab + Cobimetinib Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group XII: Stage 1: Cohort 2: Atezolizumab + Camonsertib Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group XIII: Stage 1: Cohort 2: Atezolizumab + CPI-444 Experimental Treatment 2 Interventions

Participants in the Atezolizumab + CPI-444 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group XIV: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab Experimental Treatment 3 Interventions

Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group XV: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy Experimental Treatment 3 Interventions

Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group XVI: Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib Experimental Treatment 3 Interventions

Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group XVII: Stage 1: Cohort 2: Atezolizumab + Bevacizumab Experimental Treatment 2 Interventions

Participants in Atezolizumab + Bevacizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group XVIII: Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib) Experimental Treatment 3 Interventions

Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group XIX: Stage 1: Cohort 1: Atezolizumab + RO6958688 Experimental Treatment 3 Interventions

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria. Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group XX: Stage 1: Cohort 1: Atezolizumab + Cobimetinib Experimental Treatment 2 Interventions

Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria. Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group XXI: Stage 1: Cohort 2: Docetaxel Active Control 1 Intervention

Participants in the Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or disease progression. Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6958688 or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Group XXII: Stage 1: Cohort 1: Atezolizumab + Tiragolumab Active Control 2 Interventions

Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Group XXIII: Stage 1: Cohort 1: Atezolizumab Active Control 1 Intervention

Participants in the Atezolizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

Immunotherapy, particularly with pembrolizumab or atezolizumab combined with platinum-based chemotherapy, has become an effective first-line treatment for advanced non-small cell lung cancer (NSCLC), regardless of PD-L1 expression levels.

Patients with negative PD-L1 expression and low tumor mutational burden (TMB) may not benefit from immunotherapy combinations and might be better treated with traditional platinum-based chemotherapy, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choosing wisely first line immunotherapy in non-small cell lung cancer (NSCLC): what to add and what to leave out. Proto, C., Ferrara, R., Signorelli, D., et al.[2019]

The combination of pemetrexed, platinum, and pembrolizumab shows manageable toxicity, with most severe adverse events occurring early in treatment and resolving within two weeks, indicating a favorable safety profile for long-term use.

While there was a slightly higher incidence of renal toxicity in patients receiving the pembrolizumab combination compared to those on pemetrexed alone, this did not increase with longer treatment durations, supporting the regimen's safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of pemetrexed plus platinum in combination with pembrolizumab for metastatic nonsquamous non-small cell lung cancer: A post hoc analysis of KEYNOTE-189. Garon, EB., Aerts, J., Kim, JS., et al.[2023]

Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival times of 13.8 months versus 9.6 months, respectively.

The safety profile of atezolizumab was favorable, with only 15% of patients experiencing grade 3 or 4 adverse events, compared to 43% in the docetaxel group, indicating it may be a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

Atezolizumab, cemiplimab, and pembrolizumab are established as standard first-line immunotherapy options for patients with advanced non-small cell lung cancer (NSCLC) who have high PD-L1 expression (≥50%).

The consensus among 25 Spanish lung cancer experts indicates that these therapies can be tailored to specific patient subgroups, enhancing treatment decision-making based on differences observed in pivotal clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement. Isla, D., Sánchez, A., Casal, J., et al.[2023]

In a real-life study of 121 patients with advanced non-squamous non-small cell lung cancer, the combination of pembrolizumab and chemotherapy resulted in a median progression-free survival of 9 months and overall survival of 20.6 months, demonstrating its efficacy as a first-line treatment.

The treatment was generally well-tolerated, with manageable side effects; however, 17.5% of patients experienced grade 3-4 adverse events, and there were two treatment-related deaths, indicating the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29). Renaud, E., Ricordel, C., Corre, R., et al.[2023]

In a study of 114 patients with advanced nonsquamous non-small cell lung cancer (NSCLC) negative for PD-L1, the combination of antiangiogenic therapy (bevacizumab) and chemotherapy resulted in a longer median progression-free survival (PFS) of 9.8 months compared to 6.7 months for those receiving anti-PD-L1 monoclonal antibodies plus chemotherapy.

Overall survival (OS) also favored the antiangiogenic group, although not statistically significant, indicating that bevacizumab plus chemotherapy may be a more effective first-line treatment for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy or antiangiogenic therapy plus chemotherapy as first-line treatment of patients with PD-L1(-) advanced non-squamous non-small cell lung cancer in a Chinese cohort. Xia, R., Li, Y., Yang, L., et al.[2023]

In the KEYNOTE-189 study, first-line treatment with pembrolizumab combined with pemetrexed-platinum significantly improved overall survival (OS) to a median of 22.0 months compared to 10.7 months for the placebo group, indicating a strong efficacy in treating metastatic nonsquamous non-small-cell lung cancer (NSCLC).

The combination therapy also resulted in a median progression-free survival (PFS) of 9.0 months versus 4.9 months for placebo, with benefits observed regardless of tumor PD-L1 expression or the presence of liver/brain metastases, while maintaining a similar incidence of serious adverse events between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non-Small-Cell Lung Cancer. Gadgeel, S., Rodríguez-Abreu, D., Speranza, G., et al.[2021]

The ANTELOPE trial is a phase II study comparing the efficacy of a pemetrexed-free regimen (atezolizumab, carboplatin, and nab-paclitaxel) against a pemetrexed-based regimen (pembrolizumab, cis-/carboplatin, and pemetrexed) in treating TTF-1 negative non-small cell lung adenocarcinoma (NSCLC/ADC).

This trial aims to enroll 136 participants across 30 sites in Germany, focusing on overall survival as the primary endpoint, which will help determine the best treatment approach for this specific patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of the Phase II ANTELOPE Study of Atezolizumab, Carboplatin and nab-Paclitaxel vs. Pembrolizumab, Platinum and Pemetrexed in TTF-1 Negative, Metastatic Lung Adenocarcinoma (AIO-TRK-0122). Frost, N., Bleckmann, A., Griesinger, F., et al.[2023]

Pemetrexed is a multitargeted antifolate that effectively inhibits key enzymes in the folate pathway, showing clinical activity in non-small-cell lung cancer (NSCLC) and various other solid tumors.

The addition of low-level folic acid and vitamin B12 supplements enhances the safety of pemetrexed treatment without reducing its effectiveness against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Pemetrexed (Alimta , LY231514) in lung cancer therapy. Molina, JR., Adjei, AA.[2015]

In patients with metastatic non-small-cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells, pembrolizumab significantly improves progression-free and overall survival compared to traditional platinum-based chemotherapy.

Combining pembrolizumab with standard chemotherapy (pemetrexed and a platinum drug) enhances survival outcomes regardless of PD-L1 expression, indicating a broader efficacy of this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Checkpoint Inhibition and Chemotherapy: New Era of 1st-Line Treatment for Non-Small-Cell Lung Cancer. Wang, C., Kulkarni, P., Salgia, R.[2020]

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