JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer
ConditionSmall-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHunan Province Tumor Hospital
About this trial
This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. The imaging diagnosis is the extensive stage of SCLC
2. The patient failed first-line EC+PD-L1 treatment
3 PS 0-1
Disqualifiers
1. Diagnosed as non-small cell lung cancer
2. Women during pregnancy
3. Patients with symptomatic brain metastases
4. PS≥2
Trial design
Design model
Single group
Treatments tested in this trial
JS201 combine with Lenvatinib
DrugJS201 300mg i.v Q2wLenvatinib 8mg po. Qd
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Arm AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Time frame
1 yearSecondary outcomes
1
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov