NCT02621398

Pembrolizumab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-IIIB Non-Small Cell Lung Cancer

Completed Phase 1 Results posted Last updated 16 December 2025

What this trial tests

Phase 1 trial testing 3-Dimensional Conformal Radiation Therapy in Stage II Non-Small Cell Lung Cancer in 23 participants. Completed in 29 February 2024.

Timeline

4 August 2016

Primary endpoint
24 October 2019

29 February 2024

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	4 August 2016
Primary completion	24 October 2019
Estimated completion	29 February 2024
Sites	3 locations across United States

Drugs / interventions tested

• 3-Dimensional Conformal Radiation Therapy
• Carboplatin (Carboplatin) — full drug profile →
• Intensity-Modulated Radiation Therapy
• Laboratory Biomarker Analysis — full drug profile →
• Paclitaxel — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Stage II Non-Small Cell Lung Cancer — all drugs for Stage II Non-Small Cell Lung Cancer →
• Stage IIIA Non-Small Cell Lung Cancer — all drugs for Stage IIIA Non-Small Cell Lung Cancer →
• Stage IIIB Non-Small Cell Lung Cancer — all drugs for Stage IIIB Non-Small Cell Lung Cancer →

Sponsor

Rutgers, The State University of New Jersey

Who can join

18 and older, any sex, with Stage II Non-Small Cell Lung Cancer or Stage IIIA Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of the Combination of Pembrolizumab With Paclitaxel, Carboplatin and Radiation Therapy According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Primary · Up to 30 days

The 3+3 algorithm design will be used to find the MTD. Safety will be evaluated by DLT, defined as grade 4 pneumonitis. Toxicities will be characterized based on seriousness, causality, toxicity grading, and action taken with regard to trial treatment.

Group	Value	95% CI
All Participants	200

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 2-6 Weeks -Treatment Dose Level -1; Pembrolizumab 100mg

Serious: 0

Deaths: 0

Arm 2-6 Weeks -Treatment Dose Level 1; Pembrolizumab 200mg

Serious: 2/4 (50%)

Deaths: 4/4

Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 2 Pembrolizumab 100mg

Serious: 0/4 (0%)

Deaths: 4/4

Arm: 2 Weeks Before h Chemoradiation (CRT) END Dose Level: 3 Pembrolizumab 200mg

Serious: 0/3 (0%)

Deaths: 1/3

Arm: At Start of CRT Dose Level: 4 Pembrolizumab 100mg

Serious: 0/3 (0%)

Deaths: 1/3

Arm: At Start of CRT Dose Level: 5 Pembrolizumab 200mg

Serious: 0/3 (0%)

Deaths: 2/3

Arm: At Start of CRT Dose Level: 5E Pembrolizumab 200mg

Serious: 0/6 (0%)

Deaths: 3/6

Serious adverse events (5 terms)

Reaction	System	Arm 2-6 Weeks -Treatment D…	Arm 2-6 Weeks -Treatment D…	Arm: 2 Weeks Before h Chem…	Arm: 2 Weeks Before h Chem…	Arm: At Start of CRT Dose …	Arm: At Start of CRT Dose …	Arm: At Start of CRT Dose …
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Heart failure	Cardiac disorders	—	—	—	—	—	—	—
Renal	Renal and urinary disorders	—	—	—	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—

Other adverse events (15 terms — click to expand)

Reaction	System	Arm 2-6 Weeks -Treatment D…	Arm 2-6 Weeks -Treatment D…	Arm: 2 Weeks Before h Chem…	Arm: 2 Weeks Before h Chem…	Arm: At Start of CRT Dose …	Arm: At Start of CRT Dose …	Arm: At Start of CRT Dose …
Respirtory	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Gastrointestinal disorders	Gastrointestinal disorders	—	—	—	—	—	—	—
General disorders and administration site conditions	General disorders	—	—	—	—	—	—	—
Nervous system disorders	Nervous system disorders	—	—	—	—	—	—	—
Infections and infestations	Infections and infestations	—	—	—	—	—	—	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Investigations	Investigations	—	—	—	—	—	—	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Blood and lymphatic system disorders	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Vascular	Vascular disorders	—	—	—	—	—	—	—
Cardiac disorders	Cardiac disorders	—	—	—	—	—	—	—
Endocrine disorders	Endocrine disorders	—	—	—	—	—	—	—
Psychiatric disorders	Psychiatric disorders	—	—	—	—	—	—	—
Renal	Renal and urinary disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Hypokalemia, Heart failure, Renal, Dyspnea, Colitis.

Data from ClinicalTrials.gov NCT02621398 adverse events section.

Sponsor's own description

This phase I trial studies the side effects, best dose, and best way to give pembrolizumab when given together with paclitaxel, carboplatin, and radiation therapy in treating patients with stage II-IIIB non-small cell lung cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.

Publications & conference data

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

1. Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
   Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
2. Current clinical trials testing the combination of immunotherapy with radiotherapy.
   Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
3. The intersection of radiotherapy and immunotherapy: mechanisms and clinical implications.
   Spiotto M, Fu YX, Weichselbaum RR. · · 2016 · cited 177× · PMID 28018989 · DOI 10.1126/sciimmunol.aag1266
4. SBRT combined with PD-1/PD-L1 inhibitors in NSCLC treatment: a focus on the mechanisms, advances, and future challenges.
   Chen Y, Gao M, Huang Z, Yu J, et al · · 2020 · cited 125× · PMID 32723363 · DOI 10.1186/s13045-020-00940-z
5. Emerging strategies to overcome resistance to third-generation EGFR inhibitors.
   Shi K, Wang G, Pei J, Zhang J, et al · · 2022 · cited 112× · PMID 35840984 · DOI 10.1186/s13045-022-01311-6
6. Phase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Nonrandomized Controlled Trial.
   Jabbour SK, Berman AT, Decker RH, Lin Y, et al · · 2020 · cited 107× · PMID 32077891 · DOI 10.1001/jamaoncol.2019.6731
7. Combination of immunotherapy with chemotherapy and radiotherapy in lung cancer: is this the beginning of the end for cancer?
   Lazzari C, Karachaliou N, Bulotta A, Viganó M, et al · · 2018 · cited 91× · PMID 29662546 · DOI 10.1177/1758835918762094
8. Immunotherapy with checkpoint inhibitors in non-small cell lung cancer: insights from long-term survivors.
   Nadal E, Massuti B, Dómine M, García-Campelo R, et al · · 2019 · cited 84× · PMID 30725206 · DOI 10.1007/s00262-019-02310-2