About this trial
Evaluate the efficacy and safety of Anlotinib Hydrochloride in combination with Pemetrexed and Carboplatin versus Pemetrexed and Carboplatin for advanced or locally-advanced Osimertinib-resistant non-squamous non-small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) and lung adenosquamous carcinoma mixed with squamous carcinoma;
Active brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms in 21 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms);
Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel and the distance between tumor and bronchial tree is ≤ 2 cm; or there is a significant pulmonary cavity or necrotizing tumor;
Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg after optimal medical treatment);
Trial design
Parallel
Treatments tested in this trial
Pemetrexed
DrugPemetrexed,500mg/m²,ivgtt ,d1,q3w
Carboplatin
DrugCarboplatin,AUC 5.0,ivgtt,d1,q3w,
Anlotinib
DrugAnlotinib ,12 mg,po,qd,d1-14,q3w;
Treatment groups
Trial outcomes
Primary outcomes
PFS
Progress free survival
Sponsors and contacts
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Fudan University
Lead sponsor
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Sponsor institution