336 Participants NeededMy employer runs this trial

Atezolizumab for Non-Small Cell Lung Cancer

Recruiting at 70 trial locations
No Placebo GroupAll 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 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 tests whether atezolizumab, alone or with an enzyme called recombinant human hyaluronidase, can prevent non-small cell lung cancer (NSCLC) from returning after surgery. Atezolizumab is an immunotherapy treatment that helps the immune system attack cancer cells. The trial compares these treatments to the usual practice of observation after surgery. It suits those who have had a complete surgical removal of stage I NSCLC and meet specific medical criteria, including no history of certain genetic mutations or uncontrolled health conditions. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients 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 should not have uncontrolled illnesses or be on continuous systemic corticosteroids or other immunosuppressive medications within 14 days before joining the trial. It's best to discuss your specific medications with the trial team.

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

Research has shown that atezolizumab is generally well-tolerated. In studies involving patients with non-small cell lung cancer (NSCLC), atezolizumab proved to be safe. Some patients experienced side effects, similar to those seen with other cancer treatments, and serious side effects occurred in about 27% of patients.

When combined with recombinant human hyaluronidase, known as Tecentriq Hybreza, the results remain positive. Studies indicate that this combination is safe and works as well as atezolizumab alone. This combination helps the medicine enter the body more efficiently.

Overall, both treatments have good safety records, with most side effects being manageable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about atezolizumab for non-small cell lung cancer because it works by harnessing the body's own immune system to fight cancer cells. Unlike traditional chemotherapy that directly attacks cancer cells but can also harm healthy cells, atezolizumab targets the PD-L1 protein, helping the immune system recognize and destroy cancer cells more effectively. Moreover, the combination with recombinant human hyaluronidase offers a potential new delivery method, making the treatment more convenient by allowing a quicker administration under the skin instead of the longer intravenous infusion. These features have the potential to improve both the effectiveness and the experience of treatment for patients.

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

This trial will compare observation with treatment using atezolizumab for non-small cell lung cancer (NSCLC). Studies have shown that atezolizumab can help people with advanced NSCLC live longer. Specifically, one study found that patients receiving atezolizumab lived an average of 13.8 months, compared to 9.6 months for those on another chemotherapy drug. For early-stage NSCLC, atezolizumab has significantly extended the time patients live without cancer recurrence after surgery and chemotherapy, particularly in patients with certain tumor markers (PD-L1+). Research also indicates that when combined with recombinant human hyaluronidase, it performs as well and is as safe as the intravenous form of atezolizumab. Overall, atezolizumab shows promise in preventing cancer recurrence in NSCLC patients.16789

Who Is on the Research Team?

MF

Muhammad Furqan

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

This trial is for adults with stage IA3 or IB non-small cell lung cancer who have fully recovered from surgery that completely removed their tumor. They must not have had prior treatments for this cancer, need a high PD-L1 score (≥50%), and cannot have certain gene mutations or serious ongoing illnesses.

Inclusion Criteria

My tumor does not have EGFR or ALK gene changes.
I do not have any serious uncontrolled illnesses or infections.
* Patient must have undergone adequate nodal sampling as defined by Commission on Cancer, 2020 Standard. Adequate nodal sampling includes pathological evaluation of at least one (named and/or numbered) hilar station (level 10 or higher) and at least three distinct (named and or numbered) mediastinal stations (level 2-9)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab intravenously or atezolizumab and recombinant human hyaluronidase subcutaneously every 3 weeks for up to 1 year

1 year
17 cycles (in-person)

Observation

Participants undergo observation with regular CT scans and optional blood sample collection

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

10 years
Every 6 months for 3 years, then annually for 7 years

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Atezolizumab and Recombinant Human Hyaluronidase

Trial Overview

The study compares giving atezolizumab alone or with hyaluronidase after surgery to just monitoring patients without extra treatment. The goal is to see if these drugs can better prevent the return of early-stage lung cancer than observation alone.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (atezolizumab)Experimental Treatment4 Interventions
Group II: Arm A (observation)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Effectiveness and safety of Atezolizumab in patients with ...

Atezolizumab treatment was associated with an acceptable safety profile. Results supported a known correlation between PD-L1 expression and a higher benefit of ...

Atezolizumab in advanced non-small cell lung cancer - PMC

Nonetheless, the treatment with atezolizumab improved the OS relative to platinum-based chemotherapy (23.5 vs. 10 to 12 months) for patients who received first- ...

First-Line Atezolizumab plus Chemotherapy in Extensive- ...

The median progression-free survival was 5.2 months and 4.3 months, respectively -free survival than chemotherapy alone.

Final results from TAIL: updated long-term efficacy ...

In the OAK trial, the median overall survival (OS) was 13.8 months in the atezolizumab arm compared with 9.6 months in the docetaxel arm.3. At ...

Real-world comparison of the efficacy and safety ...

Dr. Bruna Pellini presents key data comparing real-world outcomes of atezolizumab versus durvalumab in extensive-stage small cell lung cancer (ES-SCLC).

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36369159/

Surgical results of the Lung Cancer Mutation Consortium 3 trial

Conclusions: Neoadjuvant atezolizumab in resectable stage IB to IIIB non-small cell lung cancer was well tolerated, yielded a 20% major pathological response ...

Atezolizumab Versus Docetaxel in Pretreated Patients With ...

Treatment-related grade 3 or 4 AEs occurred in 27% and 16% of atezolizumab 4-year survivors, AEs that led to drug interruptions occurred in 40% and 51% of the ...

Overall survival with adjuvant atezolizumab after ...

Atezolizumab significantly improved DFS versus BSC after resection and adjuvant chemo in PD-L1+ stage II-IIIA NSCLC.

Atezolizumab for NSCLC Safe and Effective Before and ...

Atezolizumab was found to be safe and effective in patients with unresectable stage III non–small cell lung cancer (NSCLC) when administered both before and ...