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Alkylating agents

Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer

Phase 3
Recruiting
Led By Jacob M Sands
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No active auto-immune disease that has required systemic treatment within the last 2 years
No prior allogeneic tissue/solid organ transplant
Must not have
History of active malignancy
History of any lymphoproliferative disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Summary

This trial is testing the addition of the immunotherapy drug pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB IIIA or IIIB non-small cell lung cancer.

Who is the study for?
This trial is for adults with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that's been surgically removed. Participants must have recovered from surgery, not had prior lung cancer treatments, and have no active infections or serious illnesses. They should not be pregnant/nursing and must agree to contraception due to potential risks of the treatment.Check my eligibility
What is being tested?
The ALCHEMIST trial is testing if adding pembrolizumab (an immunotherapy drug) to standard chemotherapy improves survival in patients who've had surgery for certain stages of non-small cell lung cancer. It explores whether this combination can better help the immune system fight remaining cancer cells.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, infusion reactions, fatigue, skin rash and digestive issues. Chemotherapy drugs involved may lead to hair loss, nausea/vomiting, increased risk of infection and blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't needed treatment for an autoimmune disease in the last 2 years.
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I have not had a transplant of tissue or an organ from another person.
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My lung cancer was surgically removed with clear margins.
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I am a woman who can still have children and have not been through menopause for 12 months.
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I am not pregnant or breastfeeding.
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My cancer has been tested for PD-L1 using specific methods.
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I have never had hepatitis B or C.
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I have not received initial treatment for my current lung cancer.
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I don't have any serious ongoing illnesses or heart problems.
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I have never needed steroids for lung inflammation.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I don't have an active, progressing second cancer that needed treatment in the last 3 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of cancer.
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I have had a condition where lymphocytes are produced in excessive amounts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease free survival (DFS)
Secondary outcome measures
DFS between each of the arms
Incidence of adverse events
OS between each of the arms
+1 more
Other outcome measures
Patient-reported QOL
Patient-reported dyspnea and coughing
Patient-reported quality of life (QOL)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (platinum doublet, combination pembrolizumab)Experimental Treatment12 Interventions
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 ECHO as clinically indicated during screening and on the trial. Patients may undergo a MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.
Group II: Arm B (platinum doublet, sequential pembrolizumab)Experimental Treatment12 Interventions
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 ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.
Group III: Arm A (platinum doublet, observation)Active Control12 Interventions
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. Patients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial. (CLOSED AS OF UPDATE #7)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed Disodium
2015
Completed Phase 2
~280
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,958,191 Total Patients Enrolled
Jacob M SandsPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04267848 — Phase 3
~91 spots leftby Dec 2024
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