A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT05132413
Phase
PHASE3
Status
Unknown

Conditions

  • Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab — DRUG
    SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
  • Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin — DRUG
    Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
  • Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin — DRUG
    Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin

Study Details

Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs

Key Dates

First listed
Nov 24, 2021
Start date
Dec 30, 2021
Status verified
Nov 2021
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
561 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group
  • Placebo Comparator: Placebo group 1
  • Placebo Comparator: Placebo group 2

Primary Outcome Measure

Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I） [ Time Frame: 2 years ]

Central Contacts