Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

Phase 2 Recruiting 460 enrolled Shanghai Pulmonary Hospital, Shanghai, China

RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.

Timeline

Start: 2017-09-01
Primary completion: 2019-09-01
Completion: 2024-09-01

Outcome

Met primary endpoint

paper Five-year RFS in ACT-group met the prespecified primary end-point PMID 42266006 ↗

Publications

Zhou Y, Bian D, Yang F, Xu X, Shen Y, Chen L, Dai J, Xu X, Zhu Y, Zhao D, Zhang P, Liu X, Jin K, Jiang G. Adjuvant chemotherapy for resected stage-ia lung adenocarcinoma with micropapillary histologic pattern. Interdiscip Cardiovasc Thorac Surg. 2026 Jun 9:ivag165. doi: 10.1093/icvts/ivag165. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous