Health TrialsbyHealthPanel

Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy

ConditionsStage IB-IIIB NSCLCStage IIB-III NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWen-zhao ZHONG

About this trial

This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS).

Researchers will compare outcomes between two cohorts:

1. Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy; 2. Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed Informed Consent Form

Patient with age ≥ 18 and ≤75 years old, gender is not limited.

Cohort 1: Histological diagnosis of Stage IB -IIIB NSCLC without anti-cancer treatment; Cohort 2: Histological diagnosis of Stage IIB-III NSCLC with non-MPR or MPR but lymph node positivity after neoadjuvant chemoimmunotherapy; (per American Joint Committee on Cancer staging system (AJCC) staging system, 8th edition)

Participants must have had complete resection of NSCLC 60 days

Disqualifiers

Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;

Treatment with prior systemic chemotherapy at any time

Confirmed EGFR or ALK mutations

Patient has a history of active autoimmune disease or autoimmune disease that may recur

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toripalimab

    Drug

    Participants will receive Toripalimab (240 mg IV) Q3W for 17 cycles (cycle length=21 days).

  • Cisplatin-based chemotherapy

    Drug

    Cisplatin\[75 mg/m\^2 IV Q3W\]/carboplatin\[AUC 5 IV Q3W\]+paclitaxel\[260 mg/m\^2 IV Q3W\] or cisplatin\[75 mg/m\^2 IV Q3W)\]/carboplatin\[AUC 5 IV Q3W\]+ pemetrexed\[500 mg/m2 IV Q3W\],dependent on tumor histology. Participants will receive Chemotherapy for 3-4 cycles

Treatment groups

211 Participants
are divided into 2 treatment groups
Group A: Stage IB-IIIB participants following completely resection without neoadjuvant therapyExperimental treatment 2 interventions
Group B: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

2-year Disease-Free Survival

DFS was defined as the time from the start of the treatment to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Time frame
24 months

Secondary outcomes

1

Overall Survival

OS was defined as the time from the start of treatment to the date of death.

Time frame
60 months
2

Adverse events

Incidence of AE/SAE which has been confirmed correlation with treatment.

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Wen-zhao ZHONG

Lead sponsor

Guangdong Provincial People's Hospital

Sponsor institution

Shanghai Junshi Bioscience Co., Ltd.

Collaborator

Source ClinicalTrials.gov
Apply now