Atezolizumab After Chemotherapy for Lung Cancer

Not currently recruiting at 337 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must be taking: Cisplatin-based chemotherapy

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, Autoimmune diseases, Cardiovascular, 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)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether atezolizumab, a type of immune therapy, can help people with non-small cell lung cancer (NSCLC) live longer without the disease returning after surgery and chemotherapy. Researchers compare atezolizumab to the best supportive care, which focuses on managing symptoms and quality of life. People who have undergone surgery and chemotherapy for NSCLC and are now cancer-free might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken certain treatments like systemic corticosteroids or immunosuppressive medications within 14 days before randomization.

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

Research has shown that atezolizumab is generally well-tolerated by patients with non-small cell lung cancer (NSCLC). Studies have found no new safety concerns for patients using atezolizumab. Another study noted that side effects were usually manageable for patients with advanced lung cancer.

Atezolizumab has also been used safely in other treatments. It is already approved for certain types of lung cancer, indicating a known safety record. While side effects can occur, they are often similar to those seen with other cancer treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Atezolizumab is unique because it is an immunotherapy drug that works by targeting and blocking the PD-L1 protein, which can prevent the immune system from attacking cancer cells. Unlike traditional chemotherapy that directly kills cancer cells, atezolizumab unleashes the body's immune system to recognize and fight the cancer more effectively. Researchers are excited about this treatment because it offers a new way to tackle lung cancer, potentially leading to longer-lasting responses and fewer side effects compared to conventional chemotherapy.

What evidence suggests that atezolizumab might be an effective treatment for non-small cell lung cancer?

Research has shown that atezolizumab, which participants in this trial may receive, can help treat non-small cell lung cancer (NSCLC). For patients with advanced NSCLC, atezolizumab improved survival rates compared to chemotherapy alone. Specifically, studies found that patients receiving atezolizumab lived a median of 19.2 months. Atezolizumab boosts the immune system to attack cancer cells, helping to prevent the cancer from returning. This treatment offers a promising option for those seeking to lower the risk of cancer recurrence after surgery and chemotherapy. ^{1 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 who've had surgery to remove non-small cell lung cancer (NSCLC) and are now ready for chemotherapy. They should be in good physical condition with a performance status of 0 or 1, have no recent infections, not pregnant, and without a history of severe allergies to drugs used in the study. People with certain other health issues or treatments within the last five years can't join.

Inclusion Criteria

My lung cancer is at an early to mid-stage (Stage IB-IIIA).

I had lung cancer surgery 4-12 weeks ago and have recovered.

My blood and organs are functioning well.

Exclusion Criteria

I haven't taken any immune-boosting drugs in the last 4 weeks or longer.

I have had hormone therapy or radiation for cancer within the last 5 years.

I have previously been treated with CD137 agonists or immune checkpoint inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants receive up to 4 cycles of cisplatin-based chemotherapy

12 weeks

4 visits (in-person)

Randomization and Treatment

Participants are randomized to receive either atezolizumab for 16 cycles or best supportive care

48 weeks

16 visits (in-person)

Follow-up

Participants are monitored for disease-free survival and overall survival

Up to 95 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Cisplatin
• Docetaxel
• Gemcitabine
• Pemetrexed
• Vinorelbine

Trial Overview The trial tests if Atezolizumab given over 16 cycles improves survival compared to just supportive care after surgery and chemo in NSCLC patients. It's an open-label study where participants are randomly chosen to get either the drug or supportive care after their initial chemo treatment.

How Is the Trial Designed?

Group I: Atezolizumab Experimental Treatment 6 Interventions

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.

Group II: Best Supportive Care Active Control 5 Interventions

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.

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

Published Research Related to This Trial

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab combined with chemotherapy showed promising efficacy in treating advanced, treatment-naïve non-small-cell lung cancer (NSCLC), with overall response rates of 36% to 68% across different chemotherapy regimens in a study of 76 patients.

The treatment was generally well tolerated, although common severe side effects included neutropenia and anemia, indicating a manageable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non-small-cell lung cancer. Liu, SV., Camidge, DR., Gettinger, SN., et al.[2022]

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival times of 13.8 months versus 9.6 months, respectively.

The safety profile of atezolizumab was favorable, with only 15% of patients experiencing grade 3 or 4 adverse events, compared to 43% in the docetaxel group, indicating it may be a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

Atezolizumab, an immune checkpoint inhibitor, has been shown to significantly prolong overall survival in patients with advanced non-small cell lung cancer (NSCLC) who have previously received chemotherapy, based on results from the phase II POPLAR and phase III OAK trials.

The treatment is particularly effective in patients with higher PD-L1 expression, demonstrating higher objective response rates, and it has a manageable safety profile with a low incidence of immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Previously Treated Advanced Non-Small Cell Lung Cancer. Blair, HA.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9716834/

updated long-term efficacy of atezolizumab in a diverse ... In patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), atezolizumab therapy improves survival with manageable safety.

2. tecentriq.com tecentriq.com/metastatic-nsclc/results/how-tecentriq-may-help.html

Effectiveness & Safety of TECENTRIQ® (atezolizumab) for ... Median overall survival (OS) was 19.2 months for patients taking TECENTRIQ® (atezolizumab. Median OS=the length of time from the start of treatment in a ...

3. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.909027/full

Efficacy of Atezolizumab for Advanced Non-Small Cell ... OS was substantially improved by atezolizumab compared to chemotherapy-based treatment (HR 0.84; 95% CI, 0.76–0.92; p = 0.0002), according to ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1809064

First-Line Atezolizumab plus Chemotherapy in Extensive- ... Despite response rates of 60 to 65%, limited progress has been made in more than two decades; outcomes remain poor, with a median overall ...

5. tecentriq.com tecentriq.com/nsclc-after-surgery/results/how-tecentriq-may-help.html

TECENTRIQ may prevent your PD-L1+ non-small cell lung ... TECENTRIQ may prevent your PD-L1+ non-small cell lung cancer from coming back · More people were alive with TECENTRIQ than with best supportive care · Important ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38830303/

Safety and Patient-Reported outcomes of atezolizumab ... Conclusion: PPAB and PPA combinations seem tolerable and manageable in patients with stage IIIB/IV non-squamous NSCLC with oncogenic addiction (EGFR mutation or ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO-24-01681

Five-Year Survival Outcomes With Atezolizumab After ... No new safety signals were reported. IMpower010 is the first study to report survival outcomes with a ≥5-year follow-up and continued to show ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468294225000164

Effectiveness and safety of Atezolizumab in patients with ... The two-cohort non-interventional study HYPERION assessed the effectiveness and safety of atezolizumab in 353 patients with locally-advanced or metastatic ...