Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

Last updated: November 23, 2023
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Cisplatin

Placebo2

Pemetrexed

Clinical Study ID

NCT03802240
CIBI338A301
  • Ages 18-75
  • All Genders

Study Summary

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  1. Signed written informed consent before any trial-related processes;
  2. Age ≥ 18 years and <75 years male or females;
  3. Has a histologically or cytologically confirmed stage IIIB/IIIC (American JointCommittee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit forradical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
  4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematologyprior to EGFR-TKI treatment
  5. EGFR-TKI resistance, confirmed by RECIST 1.1
  6. The investigator confirms at least one measurable lesion according to RECIST 1.1. Ameasurable lesion located in the field of previous radiation therapy or after localtreatment may be selected as a target lesion if progression is confirmed; The EasternCancer Cooperative Group (ECOG) performance score of 0 or 1;

Exclusion

Exclusion criteria:

  1. Squamous cell > 10%. If small cell types are present, the subject is not eligible forinclusion.;
  2. Has previously received systemic anti-tumor treatment other than EGFR-TKI for oradvanced non-squamous NSCLC (including cytotoxic chemotherapy for radiotherapy, do notinclude other systemic treatment for other cured tumors);
  3. Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2drugs or any other stimulatory or inhibitory agents of T cell receptors (eg CTLA-4,OX-40, CD137);
  4. Has received EGFR-TKI treatment within 2 weeks;
  5. Diagnosed of immunodeficiency or has received systemic steroid therapy or any otherform of immunosuppressive therapy within 7 days prior to the first dose of studydrugs.
  6. History of pneumonitis requiring steroid therapy or the presence of interstitial lungdisease within 1 year prior to the first dose of study drugs;
  7. Symptomatic central nervous system metastases (CNS) metastasis and/or cancerousmeningitis. Hemoptysis within 3 months,
  8. Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutivedays within 2 weeks. prophylactic use of anticoagulants is allowed;

Study Design

Total Participants: 492
Treatment Group(s): 6
Primary Treatment: Cisplatin
Phase: 3
Study Start date:
July 11, 2019
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

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