← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I can be treated with platinum-based chemotherapy.
Select...
My cancer can be measured by scans.
Select...
My lung cancer is confirmed to be at a specific stage and type.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My lungs work well enough for surgery to remove my cancer.
Select...
My health, aside from lung cancer, does not limit my life expectancy.
Select...
My blood and organs are functioning well.
Select...
My cancer can be completely removed with surgery aimed at curing it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Operative and Post-operative Complications
Number of Participants With Surgical Cancellations Related to Study Treatment
Number of Participants With Surgical Delays
+2 more
Secondary outcome measures
Event Free Survival (EFS)
Percentage of Participants With ADAs to Tiragolumab
Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
+3 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
Atezolizumab
2016
Completed Phase 3
~6040
Tiragolumab
2020
Completed Phase 2
~350
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250
Gemcitabine
2017
Completed Phase 3
~2070
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,082 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,510 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you list any other trials that have leveraged Atezolizumab?

"Atezolizumab was first researched in 1997 at the City of Hope Comprehensive Cancer Center, and so far 2937 studies have been conducted. Currently 1956 trials are actively recruiting patients, with a large proportion based out of Westwood Kansas."

Answered by AI

Has Atezolizumab received regulatory approval from the FDA?

"Our evaluation of the safety profile of Atezolizumab is a 2, considering that this is a Phase-2 trial with limited evidence supporting efficacy but some data suggesting its safe use."

Answered by AI

Is there currently an open enrollment period for this research project?

"Affirmative. According to information posted on clinicaltrials.gov, this medical trial is currently accepting participants; the study was first made available on April 23rd 2021 and updated most recently in November 22nd 2022. Eighty-two individuals are required across 11 trial sites."

Answered by AI

What therapeutic treatments does Atezolizumab typically target?

"Atezolizumab is a popular therapeutic option for metastatic ureter urothelial carcinoma and has been proven useful in treating lymphomas, non-hodgkin, locally advanced non-small cell lung cancer during its first administration."

Answered by AI

How many participants are taking part in this research initiative?

"In order to administer this project, 82 participants who meet the inclusivity requirements are necessary. The sponsor of the trial, Hoffmann-La Roche, will be managing data collection from University of Kansas Cancer Center (Westwood) and Winthrop Univ Hospital (Mineola)."

Answered by AI

How many separate venues are overseeing this research endeavor?

"At present, 11 clinical trial sites are operating in tandem. These locations span Westwood, Mineola and Los Angeles as well other nearby cities. We suggest selecting the nearest site to minimize travelling requirements for prospective participants."

Answered by AI
~29 spots leftby Apr 2028