Testing Immunotherapy with Chemotherapy for Non-Small Cell Lung Cancer: ALCHEMIST Trial

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04267848

Provider View

This study is exploring whether adding the immunotherapy drug pembrolizumab to the usual chemotherapy can improve treatment outcomes for patients with certain stages of non-small cell lung cancer that has been surgically removed.

Patient Parameters

Program Overview

The ALCHEMIST trial is a phase III study investigating if adding pembrolizumab, an immunotherapy drug, to standard chemotherapy can help patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer live longer. Pembrolizumab works by helping the immune system attack cancer cells, while chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine, and paclitaxel stop cancer cells from growing and spreading. The study aims to see if this combination can increase survival times for patients whose cancer has been removed by surgery.

Description

The main goal of this study is to compare how long patients live without their cancer returning (disease-free survival) between two groups: one receiving chemotherapy followed by pembrolizumab (Arm B) and another receiving both treatments together (Arm C). Secondary goals include comparing overall survival, side effects, and quality of life between these groups.

Patients are randomly assigned to one of two groups:

  • Arm B: Patients receive chemotherapy for four cycles, followed by pembrolizumab every three weeks for up to 17 cycles or every six weeks for up to 16 cycles.
  • Arm C: Patients receive chemotherapy and pembrolizumab together for four cycles, then continue pembrolizumab every three weeks for up to 13 cycles or every six weeks for up to 12 cycles.

Patients will have regular check-ups, including heart scans, MRIs, CT scans, and blood tests, to monitor their health and the treatment's effects. After treatment, patients will be followed up regularly for up to 10 years to track their progress.

Eligibility Criteria

Inclusion Criteria

  • Women of childbearing age must not be pregnant and must use birth control.
  • Previously registered to a related study (A151216).
  • Tested negative for specific genetic mutations (EGFR and ALK) if applicable.
  • Tested for PD-L1 using specific tests.
  • Have had stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer completely removed by surgery.
  • Recovered from surgery and registered for the study 30-77 days after surgery.
  • No previous treatments for the current lung cancer diagnosis.
  • No history of organ transplants.
  • No serious ongoing illnesses that would interfere with the study.
  • No current or past lung inflammation requiring steroids.
  • HIV-positive patients must have an undetectable viral load.
  • Aged 18 or older.
  • Good overall health (ECOG status 0-1).
  • No active autoimmune diseases requiring treatment in the last 2 years.
  • Not pregnant or nursing.
  • No other active cancers requiring treatment in the last 3 years.
  • No severe allergies to pembrolizumab.
  • No recent live vaccines.
  • No history of hepatitis B or C.
  • Meet specific blood count and organ function criteria.

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