NCT04253964 is a Phase 2 clinical trial of Pembrolizumab in Nonsmall Cell Lung Cancer, sponsored by Wake Forest University Health Sciences.

Who is sponsoring NCT04253964?

NCT04253964 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT04253964?

Interventions in NCT04253964: Pembrolizumab, Carboplatin, Paclitaxel, Nab paclitaxel, Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13), QLQ-C30 Global Health/Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes, Pemetrexed.

What condition does NCT04253964 study?

NCT04253964 studies Nonsmall Cell Lung Cancer, Performance Status.

Is NCT04253964 still recruiting?

NCT04253964 is currently recruiting now. Last updated 17 March 2026.

Last reviewed 2026-03-17 · How we verify

NCT04253964

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Recruiting now Phase 2 Last updated 17 March 2026

What this trial tests

Phase 2 trial testing Pembrolizumab in Nonsmall Cell Lung Cancer in 105 participants. Currently enrolling.

Timeline

1 July 2020

Primary endpoint
1 September 2026

1 September 2026

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	1 July 2020
Primary completion	1 September 2026
Estimated completion	1 September 2026
Sites	1 location across United States

Drugs / interventions tested

Pembrolizumab (pembrolizumab) — full drug profile →
Carboplatin
Paclitaxel — full drug profile →
Nab paclitaxel
Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)
QLQ-C30 Global Health/Quality of Life Questionnaire
COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes
Pemetrexed — full drug profile →

Conditions studied

Nonsmall Cell Lung Cancer — all drugs for Nonsmall Cell Lung Cancer →
Performance Status — all drugs for Performance Status →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Nonsmall Cell Lung Cancer or Performance Status. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of Participants with Progression-Free Survival
Time frame: From baseline to end of 4th cycle of treatment (12 weeks)
Using non-blinded central imaging using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 to define progressive disease. RECIST v 1.1 criteria: * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions. * Stable Disease (SD): Not meeting criteria for CR, PR, or PD. * Progressive Disease (

Sponsor's own description

This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

First-line immunotherapy in non-small cell lung cancer patients with poor performance status: a systematic review and meta-analysis.
Facchinetti F, Di Maio M, Perrone F, Tiseo M. · · 2021 · cited 30× · PMID 34295688 · DOI 10.21037/tlcr-21-15
COPD and Immune Checkpoint Inhibitors for Cancer: A Literature Review.
Lycan TW, Norton DL, Ohar JA. · · 2024 · cited 9× · PMID 39677829 · DOI 10.2147/copd.s490252
User-centered design of a COPD care pathway for patients with cancer: a mixed-methods clinical trial protocol.
Lycan TW, Price SN, Mileham K, Stoen E, et al · · 2025 · PMID 41084760 · DOI 10.1080/14796694.2025.2562715

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Nonsmall Cell Lung Cancer

Currently open trials in the same condition.

NCT04900935 — Patient-centered, Optimal Integration of Survivorship and Palliative Care · NA · recruiting
NCT06147570 — A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer · Phase 2 · recruiting
NCT05358249 — Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation · Phase 1, PHASE2 · active not recruiting
NCT03753685 — X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases · Phase 2 · active not recruiting
NCT03778814 — TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors · Phase 1 · recruiting

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

NCT07474090 — Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial · NA · not yet recruiting
NCT07282444 — A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial · NA · not yet recruiting
NCT06876896 — Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter · NA · recruiting
NCT07227051 — Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity · NA · recruiting
NCT07215624 — Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04253964 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 17 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04253964.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing