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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 prior allogeneic tissue/solid organ transplant
No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Study 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 have not had a transplant of tissue or an organ from another person.
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I have never needed steroids for lung inflammation.
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I have not had a transplant of tissue or an organ from another person.
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I have never needed steroids for lung inflammation.
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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 am a woman who can still have children and have not been through menopause for 12 months.
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My lung cancer was surgically removed with clear margins.
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I have never needed steroids for lung inflammation.
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My non-squamous cancer does not have ALK rearrangement.
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My non-squamous cancer does not have specific EGFR mutations.
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I have fully recovered from surgery and it's been 30-77 days since.
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I have not had a transplant of tissue or an organ from another person.
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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 am fully active or can carry out light work.
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I am HIV positive, on treatment, and my viral load is undetectable.
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I haven't needed treatment for an autoimmune disease in the last 2 years.
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I am 18 years old or older.
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I am not pregnant or breastfeeding.
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I have not received a live vaccine in the last 30 days.
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I don't have an active, progressing second cancer that needed treatment in the last 3 years.

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 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Upper respiratory tract infection
8%
Pneumonia
8%
Oedema peripheral
8%
Alanine aminotransferase increased
7%
Hypokalaemia
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Nasopharyngitis
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Pulmonary embolism
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Biospecimen Collection
2004
Completed Phase 1
~1850
Computed Tomography
2017
Completed Phase 2
~2710
Echocardiography
2013
Completed Phase 4
~11670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 3
~2070
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
13,579 Previous Clinical Trials
41,223,269 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other ongoing research studies that also use Pembrolizumab?

"Pembrolizumab's first clinical trial was at City of Hope Comprehensive Cancer Center in 1997. 3404 trials have been completed since then, with 2602 presently ongoing. A large number of these active studies are based out of Brighton, Michigan."

Answered by AI

How many people are given the opportunity to participate in this experiment?

"In order to conduct this study, we need 1210 willing and eligible participants. Potential volunteers can locate a participating medical center in their area, such as Trinity Health IHA Medical Group Hematology Oncology - Brighton in Brighton, Michigan or Oncology Hematology Associates of Saginaw Valley PC in Saginaw, Pennsylvania."

Answered by AI

Could you please detail Pembrolizumab's side effects?

"Pembrolizumab has received a safety score of 3 from our Power team. This is due to the fact that it is a Phase 3 trial, meaning there is both efficacy and safety data available."

Answered by AI

Can people with the relevant medical condition join this clinical trial at present?

"Yes, this information is accurate. The clinical trial in question was originally posted on June 3rd 2020 and updated November 15th of this year."

Answered by AI

What are the main indications for Pembrolizumab?

"Pembrolizumab can help patients with hodgkin disease, as well as those that have previously received adjuvant anthracycline-containg therapy for another disease."

Answered by AI

In how many different places is this trial taking place?

"This study is being conducted at Trinity Health IHA Medical Group Hematology Oncology - Brighton in Brighton, Michigan; Oncology Hematology Associates of Saginaw Valley PC in Saginaw, Pennsylvania; UPMC Cancer Center at UPMC Horizon in Farrell, South carolina; and 100 other locations."

Answered by AI

Who else is applying?

What state do they live in?
California
Michigan
Arizona
What site did they apply to?
Banner Boswell Medical Center
Loma Linda University Medical Center
Kaiser Permanente-San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~205 spots leftby Dec 2024