Tiragolumab + Atezolizumab for Non-Small Cell Lung Cancer

No longer recruiting at 54 trial locations

Overseen By Reference Study ID Number: GO42501 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: Immunostimulants, Immunosuppressants

Disqualifiers: Autoimmune disease, Cardiovascular 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a combination of drugs to treat locally advanced, untreated non-small cell lung cancer (NSCLC). It evaluates the safety and effectiveness of administering these drugs before surgery and continuing treatment afterward. The trial includes two groups: one for patients with high PD-L1 levels (a protein related to cancer growth) and another for all PD-L1 levels. Patients with stage II or III NSCLC who are eligible for surgery and have not received prior lung cancer treatment may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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

The trial information does not specify if you need to stop taking your current medications. However, it excludes those on systemic immunosuppressive or immunostimulatory medications, so you might need to stop those if applicable.

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

Research has shown that the combination of tiragolumab and atezolizumab has been studied before. These studies primarily assessed the treatment's effectiveness and provided some safety information. For instance, patients generally tolerated the combination well, with common side effects such as tiredness and nausea, typical for cancer treatments.

While the treatment did not significantly improve survival rates, this does not imply it is unsafe. The progression to a Phase 2 trial indicates that earlier studies deemed it safe enough for broader testing. Phase 2 trials emphasize safety, so this trial will further confirm the treatment's safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of tiragolumab and atezolizumab for treating non-small cell lung cancer because it leverages a novel immune-boosting approach. While typical treatments often focus on standard chemotherapy and PD-1/PD-L1 inhibitors like pembrolizumab, this combination targets the TIGIT pathway alongside PD-L1, potentially offering a more robust immune response against cancer cells. This dual-action mechanism could enhance the body's ability to fight tumors more effectively than traditional therapies alone. Additionally, the flexibility to tailor post-surgery treatments based on patient-specific factors is a promising strategy for personalized cancer care.

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

Research has shown that using tiragolumab with atezolizumab hasn't consistently improved treatment outcomes for non-small cell lung cancer (NSCLC). Studies found that this combination did not extend patients' lives or delay cancer growth compared to atezolizumab alone, even in those with high levels of the protein PD-L1. In this trial, participants in Cohort A, with high PD-L1 expression, will receive neoadjuvant atezolizumab plus tiragolumab. Meanwhile, Cohort B, which includes participants with any PD-L1 expression level, will receive neoadjuvant atezolizumab plus tiragolumab along with chemotherapy. Despite previous results, researchers continue to explore different ways to use these drugs to determine if they might be beneficial in other situations. ^{2 4 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 untreated Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) who can have platinum-based chemotherapy and surgery. They must be in good health otherwise, not HIV positive, and without a history of certain other cancers or severe infections.

Inclusion Criteria

I can be treated with platinum-based chemotherapy.

My cancer can be measured by scans.

My lung cancer is confirmed to be at a specific stage and type.

Exclusion Criteria

My lung cancer is either small cell or has small cell components.

I have not had any cancer other than NSCLC in the last 5 years, except for those unlikely to spread or be fatal.

I have active tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant atezolizumab plus tiragolumab, with or without chemotherapy, for 4 cycles

8-12 weeks

Surgical Resection

Participants undergo surgical resection of the tumor

1 week

Adjuvant Treatment

Participants receive adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles

32-48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Carboplatin
• Cisplatin
• Tiragolumab

Trial Overview

The study tests the safety and effectiveness of Tiragolumab plus Atezolizumab alone or with chemo as pre-surgery (neoadjuvant) treatment. After surgery, patients will continue these drugs or receive chemo to prevent cancer return.

How Is the Trial Designed?

Group I: Cohort B (PD-L1 All Comers) Experimental Treatment 7 Interventions

All comers, which are participants with any PD-L1 expression level, will be enrolled in Cohort B and receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles. Chemotherapy may include: * cisplatin/carboplatin + pemetrexed (for non-squamous only) * carboplatin + gemcitabine (for squamous only) * carboplatin + paclitaxel

Group II: Cohort A (PD-L1 High) Experimental Treatment 7 Interventions

Participants with high programmed death-ligand 1 (PD-L1) expression level will be enrolled in Cohort A and receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical resection and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator. Chemotherapy may include: * cisplatin/carboplatin + pemetrexed (for non-squamous only) * carboplatin + gemcitabine (for squamous only) * carboplatin + paclitaxel

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

Citations

1.

onclive.com

onclive.com/view/tiragolumab-plus-atezolizumab-fails-to-meet-survival-end-points-in-previously-untreated-pd-l1-high-nsclc

Tiragolumab Plus Atezolizumab Fails to Meet Survival End ...

First-line tiragolumab plus atezolizumab did not improve PFS and OS vs atezolizumab alone in PD-L1–high, unresectable or metastatic NSCLC.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06267001

NCT06267001 | A Study of Tiragolumab Plus Atezolizumab ...

The purpose of this study was to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to ...

3.

gene.com

gene.com/media/press-releases/15029/2024-07-03/genentech-provides-update-on-phase-iiiii

Genentech: Press Releases | Wednesday, Jul 3, 2024

The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat ...

4.

roche.com

roche.com/media/releases/med-cor-2024-11-26

Roche reports update on Phase III SKYSCRAPER-01 study ...

SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients.

5.

docwirenews.com

docwirenews.com/post/officials-skyscraper-06-study-of-tiragolumab-plus-atezolizumab-in-nonsquamous-nsclc-intended-to-halt

SKYSCRAPER-06 Study of Tiragolumab Plus ...

“The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared [with] the comparator arm in ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04294810

NCT04294810 | A Study of Tiragolumab in Combination ...

The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants ...

7.

targetedonc.com

targetedonc.com/view/tiragolumab-plus-atezolizumab-fails-to-improve-outcomes-as-consolidation-in-nsclc

Tiragolumab Plus Atezolizumab Fails to Improve ...

Tiragolumab plus atezolizumab did not improve progression-free survival compared to durvalumab in stage III NSCLC patients post-cCRT. Median ...

8.

lungcancerstoday.com

lungcancerstoday.com/post/officials-skyscraper-06-study-of-tiragolumab-plus-atezolizumab-in-nonsquamous-nsclc-intended-to-halt

SKYSCRAPER-06 Study of Tiragolumab Plus ...

“The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared [with] the comparator arm in the intent-to- ...