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

• Status: Recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Cisplatin; Pemetrexed

Criteria

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 Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;

4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatmen

5. EGFR-TKI resistance, confirmed by RECIST 1.1

6. The investigator confirms at least one measurable lesion according to RECIST 1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed;

7. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

Exclusion criteria:

1. Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;

2. Has previously received systemic anti-tumor treatment other than EGFR-TKI (including cytotoxic chemotherapy for radiotherapy, do not include other systemic treatment for other cured tumors);

3. Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs 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 other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.

6. History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;

7. Active central nervous system (CNS) metastasis and/or cancerous meningitis.

8. Hemoptysis within 3 months,

9. Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;