Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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

Summary: The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in Chinese non-squamous NSCLC patients with EGFRm+ after EGFR-TKI failure will be investigated in this clinical trial


Eligibility: 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. EGFR mutation confirmed histologically or cytologically;
  5. EGFR-TKI resistant, any of the below;
  1. 1st or 2nd generation of EGFR-TKI resistant, confirmed T790M mutation negative;
  2. 1st or 2nd generation of EGFR-TKI resistant, confirmed T790M mutation and 3rd generation of TKI failed;
  3. 3rd generation of EGFR-TKI failed as 1st line treatment regardless T790M mutation;
  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;
  Main Exclusion Criteria:
  1. Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;
  2. Patients with known, including but not limited to, ALK rearrangements, ROS1 mutation or BRAFV600E mutation;
  3. 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);
  4. 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);
  5. Has received EGFR-TKI treatment within 2 weeks;
  6. Has received radiotherapy within 3 weeks. For those who received radiotherapy 3 weeks ago, have to fulfill all the below conditions: no adverse event relevant to radiotherapy; no need of glucocorticoid; exclude radiation pneumonitis;
  7. 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. Physiological doses of corticosteroids (≤10 mg/day of prednisone or equivalent) are permitted;
  8. History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;
  9. Active central nervous system (CNS) metastasis and/or cancerous meningitis. Patients with treated brain metastases who were clinically stable for at least 2 weeks and have no new or advanced brain metastases may be enrolled. Patients with known untreated, asymptomatic brain metastases can be enrolled provided cerebral imaging assessment be regularly performed;
  10. Hemoptysis (>2.5ml each) within 3 months,
  11. Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;

Relevance to patient case: possibly relevant