50 Participants Needed

Tiragolumab + Atezolizumab for Non-Small Cell Lung Cancer

Recruiting at 54 trial locations
RS
RS
Overseen ByReference Study ID Number: GO42501 https://forpatients.roche.com/
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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.

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.12345

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.24678

Who Is on the Research Team?

CT

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.
See 8 more

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.
See 12 more

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?
2Treatment groups
Experimental Treatment
Group I: Cohort B (PD-L1 All Comers)Experimental Treatment7 Interventions
Group II: Cohort A (PD-L1 High)Experimental Treatment7 Interventions

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

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Approved in United States as Tecentriq for:
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Approved in European Union as Tecentriq for:

Find a Clinic Near You

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 profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

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.
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 ...
Genentech: Press Releases | Wednesday, Jul 3, 2024The 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 ...
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.
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 ...
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 ...
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 ...
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- ...
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