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Comparing Treatment Before or After Surgery for Lung Cancer

This study is comparing two ways to treat stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery. One group of patients will receive standard therapy after surgery, while the other group will receive standard therapy both before and after surgery. Standard therapies may include chemotherapy drugs like cisplatin, carboplatin, pemetrexed, or gemcitabine. Researchers want to see which approach leads to better outcomes, specifically how long patients live without their cancer returning or getting worse, and overall survival. You may be eligible if you have surgically resectable stage II-IIIB NSCLC and are at least 18 years old. The study will also look at certain biomarkers (ALK, EGFR) and mechanisms (checkpoint inhibitor, immunotherapy).

Study design
This is an interventional study comparing two treatment approaches in 1100 patients. Patients will be randomly assigned to one of the two treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be followed for up to 10 years to track overall survival, and for 3 years to track event-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06632327

Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Alliance for Clinical Trials in Oncology
~37 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Surgical ProcedureCisplatinCarboplatinPemetrexedGemcitabineDocetaxel

At a glance

Recruiting sites
0 of 411 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
3-year real-world event-free survival (rwEFS)
Measured over From the date of randomization to the date of the first of the following events: failure to undergo resection for any reason, recurrence or progression at any time after surgery, or death from any cause, assessed at 3 years
+1 more outcome measured

Conditions

Resectable Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8

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Lung Non-Small Cell Carcinoma

Where it's being run

411 sites across 46 states
Illinois64
Wisconsin58
California46
Minnesota32
Missouri28
Ohio20
New York12
South Carolina11

Study leadership

  • Daniel Morgensztern, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology
  • Raid Aljumaily, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology
  • Linda Martin, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC according to the American Joint Committee on Cancer (AJCC) 9th edition (stage IIA to IIIB NSCLC up to single station N2, according to the AJCC 8th edition)
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)
No prior systemic treatment for NSCLC within 5 years except stage 1 and 2 cancers treated with curative intent
No treatment for another malignancy within 3 years prior to registration, except for stage 1 or 2 cancers treated for curative intent; patients must be disease free for one year prior to registration. Patients with non-melanoma skin cancer, urothelial carcinoma in situ (Tis), noninvasive papillary carcinoma of the urinary bladder (Ta), prostatic intraepithelial neoplasia (PIN), ductal carcinoma in situ (DCIS) of the breast, or cervical intraepithelial neoplasia (CIN) of the uterine cervix are also eligible
No active autoimmune disease, interstitial lung disease, or transplant that precludes safe treatment with immune checkpoint inhibitors
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

What this trial measures

  • 3-year real-world event-free survival (rwEFS)From the date of randomization to the date of the first of the following events: failure to undergo resection for any reason, recurrence or progression at any time after surgery, or death from any cause, assessed at 3 years

    Time to event analyses will be summarized using the Kaplan-Meier method, where both the stratified and unstratified log-rank test will be used to compare the distributions across the treatment arms. For the primary analysis of 3-year rwEFS rate, we will compare the rwEFS curves at 3 years, using the difference in Kaplan-Meier estimates for the survival functions. The test statistic will be derived from the difference in the estimated Kaplan-Meier values between two arms at 3 years, using the Greenwood estimate of the variances. rwEFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. The comparison of the rwEFS post 3-years between the two arms among patients who do not experience an event by 3 years, will involve assessing the probability of a longer rwEFS on the perioperative arm. Non-parametric estimation and inference methods will be used for analysis.

  • Overall survival (OS)From randomization until death from any cause, assessed up to 10 years

    Time to event analyses will be summarized using the Kaplan-Meier method, where both the stratified and unstratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.