Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT04506242
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 — DRUG
    PD-1
  • Apatinib — DRUG
    VEGFR2

Study Details

This trial will evaluate the safety and efficacy of Camrelizumab (SHR-1210) in combination with apatinib neoadjuvant therapy before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with resectable stage IIA-IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC).

Key Dates

Start date
Sep 15, 2020
Status verified
Sep 2020
Primary completion
Dec 30, 2021
Completion
Dec 30, 2025

Study Design

Enrollment
74 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: apatinib+ Neoadjuvant/Adjuvant camrelizumab
    Neoadjuvant: Prior to surgery, participants receive 3 cycles (cycle length: 2 weeks) of camrelizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with apatinib ,5 days on 2days off\]. Adjuvant: 4-8 weeks following surgery, participants receive up to 12 cycles (cycle length: 2 weeks) of camrelizumab \[200 mg, IV; given on cycle day 1\]. Participants who can not able to benefit from immunotherapy will not receive camrelizumab adjuvant therapy.

Primary Outcome Measure

Major Pathological Response (MPR) Rate [ Time Frame: Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12) ]

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