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Alkylating agents

Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Michael L Cheng, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically or cytologically confirmed stage IV NSCLC (AJCC 8th edition).
ECOG performance status 0-2 (see Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up he time from registration to the earlier of progression or death due to any cause or 30 months
Awards & highlights

Study Summary

This trial is looking to see if a blood test can detect early response in patients being treated for lung cancer with pembrolizumab, and if so, whether patients should continue treatment with pembrolizumab or switch to pembrolizumab in combination with chemotherapy.

Who is the study for?
Adults with stage IV Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic anti-cancer therapy for it. They must have normal organ/marrow function, a PD-L1 tumor score ≥1%, and be able to use contraception. Excluded are those with certain genetic mutations, recent chemo/radiotherapy, uncontrolled illnesses, other investigational drugs, active autoimmune diseases needing high-dose steroids, known allergies to similar drugs, pregnancy/breastfeeding women, HIV/AIDS patients or uncontrolled brain metastases.Check my eligibility
What is being tested?
The trial is testing if a blood test called InVision can predict early response in NSCLC treated with pembrolizumab alone or combined with chemotherapy (carboplatin plus pemetrexed or paclitaxel). The goal is to see if the blood test results can guide whether to continue pembrolizumab alone or add chemotherapy.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation of organs and infusion reactions. Chemotherapy agents carboplatin and pemetrexed/paclitaxel can cause hair loss, nausea/vomiting, fatigue and increased risk of infection due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is confirmed to be at stage IV.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My blood counts, liver, and kidney functions are within normal ranges, and my cancer shows some response to immunotherapy.
Select...
I am 18 years old or older.
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My cancer showed a significant decrease in specific DNA markers or remained low after starting treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~he time from registration to the earlier of progression or death due to any cause or 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and he time from registration to the earlier of progression or death due to any cause or 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6-month Progression Free Survival rate
Secondary outcome measures
Early Plasma Response
Feasibility-adherence to protocol therapy for 4 cycles
Overall Survival
+1 more

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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
Group I: Pembrolizumab Cycles 1-2Experimental Treatment2 Interventions
For the first two cycles, Pembrolizumab will be administered at a predetermined dose every 3 weeks. InVision plasma draw will take place at Cycle 1 Day 1 and Cycle 2 Day 1, with return of results to the treating oncologist prior to Cycle 3 Day 1. At Cycle 3, patients will be re-registered per the inclusion criteria into 3 arms; PEMBROLIZUMAB Alone PEMBROLIZUMAB + Doublet Chemotherapy
Group II: Pembrolizumab Alone, Cycle 3+Experimental Treatment1 Intervention
- Following imaging assessment at Cycle 3, participants will continue pembrolizumab alone if the following responses are observed: Response of Partial Response/Complete Response Response of Stable Disease with plasma response Response of Progressive Disease without worsening cancer symptoms AND plasma response
Group III: Pembrolizumab + Doublet Chemotherapy, Cycles 3+Experimental Treatment4 Interventions
Following imaging assessment at Cycle 3, participants will receive pembrolizumab in combination with platinum doublet chemotherapy if they have a response of stable disease without plasma response, OR no plasma response and response of progressive disease without worsening cancer systems. Platinum doublet should be histology-appropriate and will be given on-label, per treating oncologist. PEMBROLIZUMAB Chemotherapy multiple agents systemic PEMETREXED CARBOPLATIN PACLITAXEL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
CARBOPLATIN
2005
Completed Phase 2
~80
PACLITAXEL
2013
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,832 Total Patients Enrolled
Julia K. Rotow, MDLead Sponsor
InivataIndustry Sponsor
4 Previous Clinical Trials
658 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04166487 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Pembrolizumab Cycles 1-2, Pembrolizumab Alone, Cycle 3+, Pembrolizumab + Doublet Chemotherapy, Cycles 3+
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04166487 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166487 — Phase 2

Frequently Asked Questions

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

Is Pembrolizumab a new or novel drug?

"Pembrolizumab is being studied in 442 Phase 3 trials and 2127 studies overall. Many of these Pembrolizumab trials are located throughout China, with 94696 research sites in total."

Answered by AI

How many people will be taking part in this clinical trial at its largest?

"The most recent information available indicates that this study is still actively recruiting patients. The trial was initially posted on 1/13/2020, and the latest update was on 6/6/2022. Currently, there are 5 locations where the clinical trial is being conducted and they are looking for a total of 40 patients."

Answered by AI

Are we still looking for volunteers for this experiment?

"This study, which was first posted on January 13th 2020 and last edited on June 6th 2022, is currently seeking patients, as reported on clinicaltrials.gov."

Answered by AI

What is Pembrolizumab's common applications in treatment?

"Pembrolizumab is a medication that oncologists often prescribe to treat malignant neoplasms. It can also help patients with locally advanced nonsquamous non-small cell lung cancer, unresectable melanoma, and microsatellite instability high."

Answered by AI

Has Pembrolizumab received regulatory approval from the FDA?

"While there is some data supporting the safety of Pembrolizumab, it is only from Phase 2 trials meaning that its efficacy has not been proven. As such, we have given it a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Plasma-Adapted First-Line Pembro In NSCLC
Julia K. Rotow, MD 2020. "Plasma-Adapted First-Line Pembro In NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04166487.
~1 spots leftby Jun 2024
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