NCT04061590

Pembrolizumab With or Without Chemotherapy Before Surgery in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer

Withdrawn Phase 2 Last updated 4 March 2022

What this trial tests

Phase 2 trial testing Cisplatin in Lung Non-Small Cell Carcinoma. Withdrawn.

Timeline

29 May 2020

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	29 May 2020
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Cisplatin (cisplatin) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Pemetrexed — full drug profile →
• Pemetrexed Disodium — full drug profile →
• Therapeutic Conventional Surgery

Conditions studied

• Lung Non-Small Cell Carcinoma — all drugs for Lung Non-Small Cell Carcinoma →
• Stage I Lung Cancer AJCC v8 — all drugs for Stage I Lung Cancer AJCC v8 →
• Stage IA1 Lung Cancer AJCC v8 — all drugs for Stage IA1 Lung Cancer AJCC v8 →
• Stage IA2 Lung Cancer AJCC v8 — all drugs for Stage IA2 Lung Cancer AJCC v8 →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Lung Non-Small Cell Carcinoma or Stage I Lung Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well pembrolizumab with or without chemotherapy works when given before surgery in treating patients with stage I-IIIA non-small cell lung cancer. Immunotherapy with pembrolizumab, may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and pemetrexed, 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. Giving pembrolizumab with or without chemotherapy may shrink the cancer prior to surgery and decrease the likelihood of the cancer returning following surgery.

Publications & conference data

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

1. Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives.
   Godoy LA, Chen J, Ma W, Lally J, et al · · 2023 · cited 34× · PMID 36650586 · DOI 10.1186/s40364-022-00444-7
2. Neoadjuvant treatment in non-small cell lung cancer: New perspectives with the incorporation of immunotherapy.
   Aguado C, Chara L, Antoñanzas M, Matilla Gonzalez JM, et al · · 2022 · cited 23× · PMID 35662985 · DOI 10.5306/wjco.v13.i5.314
3. Neoadjuvant and Adjuvant Immunotherapy in Early-Stage Non-Small Cell Lung Cancer.
   Shukla N, Hanna N. · · 2021 · cited 20× · PMID 34234606 · DOI 10.2147/lctt.s277717
4. Surgery after Induction Targeted Therapy and Immunotherapy for Lung Cancer.
   Allaeys T, Berzenji L, Van Schil PE. · · 2021 · cited 18× · PMID 34073302 · DOI 10.3390/cancers13112603
5. Expert consensus on perioperative immunotherapy for local advanced non-small cell lung cancer.
   Qiu B, Cai K, Chen C, Chen J, et al · · 2021 · cited 17× · PMID 34733623 · DOI 10.21037/tlcr-21-634
6. Expert consensus on perioperative treatment for non-small cell lung cancer.
   Duan J, Tan F, Bi N, Chen C, et al · · 2022 · cited 13× · PMID 35958323 · DOI 10.21037/tlcr-22-527
7. Adjuvant and neo-adjuvant immunotherapy in resectable non-small cell lung cancer (NSCLC): Current status and perspectives.
   Xu Z, Zou Z, Hao X, Xing P, et al · · 2023 · cited 7× · PMID 38090369 · DOI 10.1002/cai2.49
8. Multimodality Treatment including Surgery Related to the Type of N2 Involvement in Locally Advanced Non-Small Cell Lung Cancer.
   Allaeys T, Berzenji L, Lauwers P, Yogeswaran SK, et al · · 2022 · cited 7× · PMID 35406428 · DOI 10.3390/cancers14071656