A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHunan Cancer Hospital
About this trial
The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Histologically or cytologically confirmed mixed SCLC and NSCLC;
Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
Previous thoracic radiotherapy;
Trial design
Design model
Single group
Treatments tested in this trial
Sugemalimab and Chemotherapy
DrugChemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: Interventional armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Objective response rate
Time frame
From the initiation of the first dose to 3 yearsSecondary outcomes
1
PFS
Progression-free survival
Time frame
From the initiation of the first dose to 3 years2
OS
Overall survival
Time frame
From the initiation of the first dose to 3 years3
iORR
Objective response rate after induction therapy
Time frame
From the initiation of the first dose to 3 years4
AEs
Adverse events
Time frame
From the initiation of the first dose to 90 days after the last doseSponsors and contacts
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Source ClinicalTrials.gov