Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT04379739
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    camrelizumab 200mg, q3w, i.v., 2-4 cycles;

Study Details

Immunotherapy with anti-programmed death 1 (PD-1) antibodies has revolutionized the treatment of metastatic and advanced NSCLC, but its application in neoadjuvant setting has not been well established. Results from a pilot clinical study reported the safety and feasibility of neoadjuvant PD-1 blockade. There are several neoadjuvant immunotherapy (NEOSTAR, LCMC3, NADIM, IMpower131) ongoing, and the preliminary results are reported in 2019 American Society of Clinical Oncology, which show promising therapeutic prospect. However, the therapeutic response rate (major pathologic response \[MPR\]) are not so good (20% - 45%) for PD-1 inhibitor monotherapy. To improve the therapeutic response, the investigators design a multiple-canter, open-label, phase II trial for stage II-III potentially resectable (resectable and initially unresectale) NSCLC. The participants will receive neoadjuvant PD-1 inhibitor (camrelizumab) combined with antiangiogenic drug (apatinib) or platinum-based chemotherapy.

Key Dates

Start date
Jul 26, 2020
Status verified
Nov 2023
Primary completion
Jun 29, 2022
Completion
Dec 30, 2026

Study Design

Enrollment
89 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: camrelizumab + apatinib
    Neoadjuvant treatment stage: camrelizumab 200mg, q3w, i.v., 2-4 cycles; apatinib 250 mg, qd, p.o. 3 weeks per cycle, 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery 3-4 weeks after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.
  • Experimental: camrelizumab + platinum-based chemotherapy
    Neoadjuvant treatment stage: camrelizumab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (squamous: carboplatin AUC5, gemcitabine 1000mg/m2; non-squamous: carboplatin AUC5, pemetrexed 500mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery 3-4 weeks after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.

Primary Outcome Measure

Major pathologic response (MPR) [ Time Frame: up to 5 months ]

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