Atezolizumab for Early Stage Lung Cancer Recurrence

Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial

Recruiting Phase 3 Interventional Study
Lung Non-Small Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
336 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for patients who have had surgery for early-stage non-small cell lung cancer. Participants will either receive a medication called atezolizumab or be monitored without additional treatment to see if it helps prevent the cancer from returning.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with stage IA3 or IB non-small cell lung cancer.
  • I have had complete surgical removal of my lung cancer.
  • I have adequate nodal sampling as defined by the latest standards.
  • I have a PD-L1 tumor proportion score of 50% or higher.
  • I am at least 18 years old.
  • I have an Eastern Cooperative Oncology Group performance status of 2 or lower.
  • I am not pregnant and not nursing.

You may not be able to join if

  • I have uncontrolled serious illness.
  • I have a history of pneumonitis that required steroids.
  • I have an active autoimmune disease that needed systemic treatment in the last 2 years.
  • I have a known severe allergy to atezolizumab.
  • I have received continuous treatment with certain systemic steroids in the past 14 days.
  • I received a live vaccine within 30 days prior to registration.
  • I have had a bone marrow, stem cell, or organ transplant.
  • I have active hepatitis B or C.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Pathologically stage IA3 or IB NSCLC per American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 9th edition * Note: Tumors with any histology are allowed including both squamous and non-squamous subtypes, except those containing small-cell morphology. Non-squamous…
Contacts

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