Trials / Recruiting

RecruitingNCT04267848

Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])

Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)

Status: Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 1,210 (estimated)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVE: I. To compare the disease free survival (DFS) between Arm B versus (vs) Arm C in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. SECONDARY OBJECTIVES: I. To compare the overall survival (OS) between the two treatment arms in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. II. To compare the adverse event rates and drug discontinuation rates due to adverse events in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. III. To compare the adverse event (AE) rates for Arms B and C with A (prior to Update #7) and estimate the DFS and OS in Arm A. IV. To compare the DFS and OS in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer that receive at least 2 cycles of initial adjuvant chemotherapy. QUALITY OF LIFE OBJECTIVES: I. To compare patient-reported quality of life (QOL) one year after randomization as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core (C)30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B), and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C). II. To compare patient-reported QOL at completion of chemotherapy as assessed by the EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B) and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C). III. To present longitudinal trajectories by arm of patient-reported dyspnea and coughing as assessed by the EORTC QLQ-Lung Cancer (LC13). CORRELATIVE SCIENCE OBJECTIVES: I. To compare the DFS and OS in the PD-L1 subgroup of patients with PD-L1 expression status (\>= 1% vs \< 1%). II. To compare the DFS and OS by tumor mutational burden status (high vs. low) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (CLOSED AS OF UPDATE #7 on 2/1/2022): INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens\* based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then undergo observation. ARM B: INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens\* based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 17 cycles or every 6 weeks for 16 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity. ARM C: INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens\* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10/14/2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiogram (ECHO) as clinically indicated during screening and on the trial. Patients may undergo magnetic resonance imaging (MRI) during screening and as clinically indicated on the trial, as well as computed tomography (CT) and blood sample collection throughout the trial. \*ACCEPTABLE REGIMENS: DOUBLET I: Patients receive cisplatin IV and pemetrexed IV over 10 minutes on day 1 of each cycle. DOUBLET II: Patients receive carboplatin IV over and pemetrexed IV over 10 minutes on day 1 of each cycle. DOUBLET III: Patients receive cisplatin IV on day 1 of each cycle and gemcitabine hydrochloride IV on days 1 and 8 of each cycle. DOUBLET IV: Patients receive carboplatin IV and paclitaxel IV over 1-96 hours on day 1 of each cycle. After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for 2 years from randomization, every 6 months for years 2-4 from randomization, and then annually for up to 10 years from randomization.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DRUG	Carboplatin	Given IV
DRUG	Cisplatin	Given IV
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Echocardiography Test	Undergo ECHO
DRUG	Gemcitabine Hydrochloride	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Observation Activity	Undergo observation
DRUG	Paclitaxel	Given IV
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Pemetrexed Disodium	Given IV
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2020-06-16
Primary completion: 2027-01-31
Completion: 2027-01-31
First posted: 2020-02-13
Last updated: 2026-04-17

Locations

1,150 sites across 2 countries: United States, Guam

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04267848. Inclusion in this directory is not an endorsement.