Atezolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 8 trial locations

Overseen By Thao Nguyen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nasser Hanna

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: EGFR mutations, ALK re-arrangements, Autoimmune disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a potential new treatment for non-small cell lung cancer (NSCLC) that has been surgically removed but might still have traces left, known as ctDNA. The treatment combines atezolizumab (Tecentriq, an immune checkpoint inhibitor) with chemotherapy to determine if it can reduce the chance of cancer recurrence. It targets individuals who had surgery for NSCLC with tumors at least 4 cm in size or certain other early stages, provided they have detectable ctDNA after surgery. Participants should have undergone surgery for their lung cancer within the last 60 days and must not have small cell or large cell neuroendocrine cancer types. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, prior chemotherapy, radiation therapy, or immunotherapy for this lung cancer is not allowed, and certain conditions like active infections or immunodeficiency might affect eligibility. It's best to discuss your specific medications with the trial team.

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

Research has shown that the combination of atezolizumab, cisplatin, and either pemetrexed or docetaxel has been tested for safety in treating non-small cell lung cancer (NSCLC). Studies have found that the atezolizumab-cisplatin-pemetrexed mix is generally well-tolerated. Common side effects include tiredness and nausea, typical with these treatments. Serious side effects are less common but can occur, so monitoring remains important.

Similarly, the atezolizumab-cisplatin-docetaxel combination has also been studied. Results suggest that patients may experience similar side effects, such as tiredness and low blood cell counts. Again, serious side effects are possible but infrequent.

The FDA has approved atezolizumab for treating other types of cancer, providing some reassurance about its safety. When combined with chemotherapy drugs like cisplatin, the treatment seems to cause manageable side effects. However, individual responses can vary, so guidance from a healthcare professional is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Atezolizumab and chemotherapy for non-small cell lung cancer because it introduces a novel approach by incorporating immunotherapy with traditional chemotherapy. Atezolizumab is an immune checkpoint inhibitor that targets the PD-L1 protein, helping the immune system recognize and attack cancer cells more effectively. This is different from the standard chemotherapy treatments, which typically involve drugs like Cisplatin and Pemetrexed or Docetaxel alone, focusing on directly killing cancer cells. By combining Atezolizumab with chemotherapy, there's potential for a more comprehensive attack on the cancer, potentially improving outcomes and offering new hope for patients with this condition.

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

Research shows that atezolizumab, when combined with chemotherapy, may help treat non-small cell lung cancer (NSCLC). This trial evaluates two different treatment combinations. For non-squamous cell tumors, participants receive atezolizumab, pemetrexed, and cisplatin. Studies have found that this combination can improve survival rates in patients with advanced NSCLC. For squamous cell tumors, participants receive atezolizumab with docetaxel and cisplatin. Earlier studies showed that this combination is effective, improving survival compared to chemotherapy alone. Researchers closely monitor the combination of atezolizumab and chemotherapy for its potential to improve treatment outcomes for early-stage NSCLC. ^{2 3 4 6 7}

Who Is on the Research Team?

Nasser Hanna, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults who've had surgery to remove certain stages of non-small cell lung cancer and have detectable ctDNA, indicating a risk of recurrence. They must be in good health with proper organ function, not pregnant or breastfeeding, willing to use contraception, and haven't received prior treatments for this cancer. People with other active cancers, severe allergies to atezolizumab or its components, autoimmune diseases, infections like HIV or hepatitis B/C are excluded.

Inclusion Criteria

My lung cancer is either squamous or non-squamous.

I understand and can follow the study's procedures.

I have been mostly active and able to carry out all my pre-disease activities up to a month ago.

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I have not had chemotherapy, radiation, or immunotherapy for this lung cancer.

I finished treatments for a previous cancer more than 3 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adjuvant Chemotherapy + Atezolizumab

Participants receive 4 cycles of adjuvant chemotherapy with Cisplatin-based regimen and concomitant Atezolizumab

3 months

Atezolizumab Extension

Participants continue with up to 13 additional cycles of Atezolizumab

10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Cisplatin

Trial Overview The study tests if adding the drug Atezolizumab to standard chemotherapy after surgery can prevent cancer from coming back in patients with specific stages of lung cancer who have signs of residual disease (ctDNA). It will check if clearing ctDNA from blood correlates with longer periods without disease and overall survival.

How Is the Trial Designed?

Group I: SC: Squamous cell tumors Experimental Treatment 3 Interventions

Atezolizumab 1200mg, Docetaxel 60-75 mg/m\^2, Cisplatin 60-75 mg/m\^2

Group II: NSC: Non-squamous cell tumors Experimental Treatment 3 Interventions

Atezolizumab 1200mg, Pemetrexed 500 mg/m\^2, Cisplatin 60-75 mg/m\^2

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?

Nasser Hanna

Lead Sponsor

Trials

4

Recruited

150+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

Atezolizumab combined with chemotherapy showed promising efficacy in treating advanced, treatment-naïve non-small-cell lung cancer (NSCLC), with overall response rates of 36% to 68% across different chemotherapy regimens in a study of 76 patients.

The treatment was generally well tolerated, although common severe side effects included neutropenia and anemia, indicating a manageable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non-small-cell lung cancer. Liu, SV., Camidge, DR., Gettinger, SN., et al.[2022]

In a study of 124 patients with treatment-naïve, metastatic nonsquamous PD-L1-positive non-small cell lung cancer, the combination of atezolizumab with carboplatin and nab-paclitaxel showed significantly improved overall survival (19.9 months) and progression-free survival (8.5 months) compared to carboplatin and nab-paclitaxel alone (14.8 months and 5.1 months, respectively).

While the combination therapy had a higher incidence of manageable adverse events like neutropenia and anemia, it still demonstrated a tolerable safety profile, suggesting it could be an effective first-line treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin and nab-paclitaxel chemotherapy with or without atezolizumab as front-line management for treatment-naïve metastatic nonsquamous non-small cell lung cancer with PD-L1 staining: a retrospective study. Xu, B., Cheng, H., Li, K., et al.[2023]

Atezolizumab therapy significantly improves overall survival (median OS of 11.2 months) in patients with previously treated advanced non-small cell lung cancer (NSCLC), demonstrating its efficacy in a diverse patient population.

The treatment has a manageable safety profile, with serious adverse events occurring in only 8.0% of patients and no new safety signals identified, indicating it is a viable option for patients often excluded from clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final results from TAIL: updated long-term efficacy of atezolizumab in a diverse population of patients with previously treated advanced non-small cell lung cancer. Ardizzoni, A., Azevedo, S., Rubio-Viqueira, B., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

In a phase 2 study involving 199 treatment-naïve patients with advanced non-squamous non-small-cell lung cancer, the combination of cisplatin, pemetrexed, and bevacizumab (CisPemBev) showed a statistically significant improvement in progression-free survival (PFS) compared to carboplatin, paclitaxel, and bevacizumab (CarPacBev), with a median PFS of 7.6 months versus 7.0 months.

Both treatment regimens were well tolerated, but CisPemBev had a lower incidence of grade ≥3 adverse events (67%) compared to CarPacBev (82%), suggesting it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab plus platinum-based chemotherapy in advanced non-squamous non-small-cell lung cancer: a randomized, open-label phase 2 study (CLEAR). Udagawa, H., Sugiyama, E., Harada, T., et al.[2022]

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

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]

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]

In a phase 3 trial with 572 patients, atezolizumab significantly improved overall survival by 7.1 months compared to platinum-based chemotherapy in patients with metastatic non-small-cell lung cancer (NSCLC) and high PD-L1 expression (20.2 months vs. 13.1 months).

Atezolizumab also demonstrated a favorable safety profile, with fewer grade 3 or 4 adverse events (30.1%) compared to chemotherapy (52.5%), indicating it may be a safer first-line treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. Herbst, RS., Giaccone, G., de Marinis, F., et al.[2022]

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab, a PD-L1 blocking antibody, shows higher rates of objective response, progression-free survival, and overall survival when used as a first-line therapy in chemotherapy-naïve patients with metastatic non-small cell lung cancer (NSCLC), compared to its use in later treatment lines.

The review included 15 ongoing studies, with 5 reporting results, indicating that atezolizumab is being explored in various treatment combinations and settings, suggesting its potential as a versatile first-line treatment option for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. Ryu, R., Ward, KE.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9253603/

Efficacy of Atezolizumab for Advanced Non-Small Cell ... The aims of this study are to clarify the potency of atezolizumab-based therapy in advanced NSCLC patients with different clinical and molecular features.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1917346

Atezolizumab for First-Line Treatment of PD-L1–Selected ... Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804918315181

Long-term survival in patients with advanced non–small ... In the primary analysis (data cut-off: July 7, 2016; median follow-up, 21 months), overall survival (OS) improved with atezolizumab (median, 13.8 months) versus ...

4. tecentriq-hcp.com tecentriq-hcp.com/metastatic-nsclc/efficacy/impower110-trial-information.html

IMpower110 Trial Information | TECENTRIQ® (atezolizumab) A Phase III, multicenter, international, randomized, open-label trial in chemotherapy-naive PD-L1+ patients with squamous or non-squamous mNSCLC.

5. tecentriq.com tecentriq.com/metastatic-nsclc/results/how-tecentriq-may-help.html

Effectiveness & Safety of TECENTRIQ® (atezolizumab) for ... TECENTRIQ helped people with a type of metastatic non-small cell lung cancer (NSCLC) live longer. TECENTRIQ was studied in 4 clinical trials with over 2000 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6940240/

Safety outcomes in advanced non-small-cell lung cancer ... We analyzed the treatment patterns and safety outcomes of the most common first-line platinum-based regimens initiated on or after non-small cell lung cancer ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03976518

Atezolizumab in Advanced Non-small Cell Lung Cancer ... This study is aimed to explore the antitumor activity and the safety profile of atezolizumab in pretreated advanced NSCLC patients with rare histological ...