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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

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 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
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

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
~5810
Gemcitabine
2017
Completed Phase 3
~1920
Atezolizumab
2017
Completed Phase 3
~5850
Tiragolumab
2019
Completed Phase 3
~1400
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~2360
Pemetrexed
2014
Completed Phase 3
~5550

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,093,072 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
892,366 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04832854 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Cohort A (PD-L1 High), Cohort B (PD-L1 All Comers)
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04832854 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04832854 — Phase 2
~26 spots leftby Apr 2028
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