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Alkylating agents

Pembrolizumab for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Naiyer Rizvi, MD

Research Sponsored by Naiyer Rizvi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NSCLC patients of all histologies may enroll to Cohorts 1 and 2. Only patients of non-squamous histologies may enroll to Cohort 3. If enrollment to a cohort is completed, enrollment may continue to other open cohorts.

Be willing and able to provide written informed consent/assent for the trial.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will test if a specific gene mutation makes people more sensitive to a certain cancer drug, either by itself or in combination with another type of chemotherapy.

Eligible Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Number of Subjects With NSCLC Who Achieved DCB

Secondary outcome measures

Objective Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment3 Interventions

Subject will receive pembrolizumab 200 mg IV every 3 weeks for up to 2 years with 2 cycles of pemetrexed and carboplatin administered with cycles 1 and 2.

Group II: Cohort 2Experimental Treatment3 Interventions

Subjects will receive pembrolizumab 200 mg IV every 3 weeks for up to 2 years with 2 cycles of nab-paclitaxel and carboplatin administered with cycles 1 and 2.

Group III: Cohort 1Experimental Treatment1 Intervention

Subjects will receive single agent pembrolizumab 200 mg IV will be administered every 3 weeks for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed

FDA approved

Pembrolizumab

FDA approved

Carboplatin

FDA approved

Paclitaxel

FDA approved

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,638 Previous Clinical Trials

40,929,800 Total Patients Enrolled

Massachusetts General HospitalOTHER

2,925 Previous Clinical Trials

13,197,884 Total Patients Enrolled

Naiyer RizviLead Sponsor

Frequently Asked Questions

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

Is this research endeavor currently accepting new participants?

"According to clinicaltrials.gov, the posting for this medical trial has not been updated since December 10th 2019 and is thus not currently recruiting patients. However there are 5688 active trials that may be accepting new participants."

Answered by AI

What ailments is Pembrolizumab commonly administered for?

"Pembrolizumab is the primary medication used to address malignant neoplasms. This immunotherapy can also be successful in treating cases of unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

How many participants are being monitored as part of this clinical experiment?

"The clinical trial is not currently recruiting patients, as it was last edited on December 10th 2019. For those who are still seeking medical trials to join, there are 3657 studies enrolling individuals with carcinoma or non-small cell lung cancer and 2031 investigations using pembrolizumab looking for participants."

Answered by AI

What potential risks do patients face when taking Pembrolizumab?

"Our evaluation of Pembrolizumab's safety scored it a 2, as the Phase 2 trial has provided evidence that this medication is generally safe but there are no studies to prove its efficacy."

Answered by AI

What other trials have been conducted pertaining to Pembrolizumab?

"Initially studied in 1997 at the City of Hope Comprehensive Cancer Center, pembrolizumab has since been part of an expansive body of research with 1971 completed studies. Currently there are 2031 live trials for this drug, some taking place in Philadelphia, Pennsylvania."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase I Study of Single-agent Anti–programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates

Brahmer, Julie R., Charles G. Drake, Ira Wollner, John D. Powderly, Joel Picus, William H. Sharfman, Elizabeth Stankevich, et al.. 2010. “Phase I Study of Single-agent Anti–programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2009.26.7609.

NatureJournal

Expression of Tumour-specific Antigens Underlies Cancer Immunoediting

DuPage, Michel, Claire Mazumdar, Leah M. Schmidt, Ann F. Cheung, and Tyler Jacks. 2012. “Expression of Tumour-specific Antigens Underlies Cancer Immunoediting”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature10803.

Cancer ResearchJournal

Exploiting the Mutanome for Tumor Vaccination

Castle, John C., Sebastian Kreiter, Jan Diekmann, Martin Löwer, Niels van de Roemer, Jos de Graaf, Abderraouf Selmi, et al.. 2012. “Exploiting the Mutanome for Tumor Vaccination”. Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/0008-5472.can-11-3722.

Science Translational MedicineJournal