Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pemetrexed

    Drug

    Pemetrexed,500mg/m²,ivgtt ,d1,q3w

  • Carboplatin

    Drug

    Carboplatin,AUC 5.0,ivgtt,d1,q3w,

  • Anlotinib

    Drug

    Anlotinib ,12 mg,po,qd,d1-14,q3w;

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Pemetrexed and Carboplatin with AnlotinibExperimental treatment 3 interventions
Group B: Pemetrexed and Carboplatin without AnlotinibActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

PFS

Progress free survival

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Sponsor institution