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Monoclonal Antibodies

Tiragolumab + Atezolizumab for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible to receive a platinum-based chemotherapy regimen

Measurable disease, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Must not have

Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC

Active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new two-drug combo as a possible treatment for lung cancer. The drugs will be given before surgery, and then again after surgery if it is successful.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in different body parts, infusion-related reactions from the drug entering the bloodstream, fatigue, blood disorders like anemia or clotting issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can be treated with platinum-based chemotherapy.

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My cancer can be measured by scans.

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lungs work well enough for surgery to remove my cancer.

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My cancer can be completely removed with surgery aimed at curing it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have active tuberculosis.

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My cancer has a ROS1 gene change.

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I am currently receiving treatment that boosts my immune system.

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My lung cancer is a specific type, like large cell neuroendocrine or sarcomatoid.

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I have previously been treated with specific immune therapies.

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I am currently taking medication that weakens my immune system.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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My lung cancer has a specific genetic change.

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I have a serious heart condition.

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I have received treatment for lung cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (PD-L1 All Comers)Experimental Treatment7 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 Treatment7 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Gemcitabine

2017

Completed Phase 3

~1920