Skip to main content

Advertisement

Table 1 Patient inclusion and exclusion criteria

From: The ACTIVE study protocol: apatinib or placebo plus gefitinib as first-line treatment for patients with EGFR-mutant advanced non-small cell lung cancer (CTONG1706)

Key inclusion criteria
 1. Age of 18–75 years at enrollment
 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–1
 3. Life expectancy of ≥ 12 weeks
 4. Histologically confirmed stage IIIB (unsuitable for radiotherapy) or IV non-squamous NSCLC, with measurable tumor lesions (on computed tomography [CT] scan according to the Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
 5. Primary NSCLC harboring activating EGFR mutation (exon 19 deletion or L858R point mutation in exon 21) confirmed with any validated methods, and the mutation detection required to be undergone prior to the trial in newly diagnosed IIIB-IV non-squamous NSCLC
 6. No history of prior chemotherapy or other targeted therapy
 7. Prior radiotherapy allowed to < 25% of the bone marrow (Cristy and Eckerman 1987)
 8. Adequate organ function (hematological, renal, hepatic, coagulation)
 9. Participants joining the trial based on the personal decision, providing written informed consent, with good compliance to treatment and follow-up
Key exclusion criteria
 1. Symptomatic brain metastases
 2. Imaging assessments (with CT or MRI) showing the distance of tumor to major blood vessels ≤ 5 mm, or presence of central tumor invasion of local major blood vessels; or evidence of pulmonary cavitary or necrotic tumor
 3. Patients with hypertension under ongoing treatment with 2 or more antihypertensive agents
 4. Detection of ALK fusions or T790M mutation positive by gene testing
 5. Presence of cardiovascular diseases; coexistence or history of interstitial lung disease; abnormalities of coagulation test; presence of clinically problematic bleeding disorders or significant bleeding tendencies; presence of documented arterial and venous thrombotic events and so on
 6. Hemoptysis with 2 teaspoons or more of bloody sputum every day before enrollment
 7. Urine test showing urine protein ≥ ++, or evidence of 24-h urine for total protein ≥ 1.0 g
 8. Pregnancy or lactation; reproductive-age women unwilling or unable to use an effective contraceptive method