Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer (NCT04422392) | Clinical Trial Compass
TerminatedPhase 2
Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer
Stopped: since the CheckMate816 study is published in NEJM, enrolling patients becomes difficult
China93 participantsStarted 2020-07-13
Plain-language summary
This is a randomized, open label study designed to evaluate the efficacy and safety of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA-N2 non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent provided.
* Males or females aged ≥18 years.
* Pathologically diagnosed of non-small cell lung cancer.
* Diagnosed as stage IIIA- N2.The diagnosis standard of N2 is as below: Pts with resectable stage IIIA-N2 NSCLC confirmed by mediastinoscopy or EBUS and PET/CT.
* Tumor should be considered resectable before study entry by a multidisciplinary team.
* ECOG (Performance status) 0-1.
* Screening laboratory values must meet the following criteria and should be obtained within 7 days prior to randomization.
i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 x×109/L iii. Hemoglobin \> 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or \>40% predicted value viii. INR/APTT within normal limits.
* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomization.
* All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
* Patient capable of pr…
What they're measuring
1
PFS at 24 months
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Trial details
NCT IDNCT04422392
SponsorShanghai Pulmonary Hospital, Shanghai, China