RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Participants will: Take RC148 or Tislelizumab combined with platinum-based chemotherapy until the end of the research.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the study and signed the Informed Consent Form (ICF).

Be willing to and able to participate in the trial and comply with the follow up procedures;

Male or female, aged 18-75 years.

Expected survival ≥ 3 months.

Disqualifiers

Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer.

Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist.

Presence of active brain metastases.

Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RC148 plus Carboplatin and Paclitaxel

    Drug

    RC148, Carboplatin, Paclitaxel

  • Tislelizumab plus Carboplatin and Paclitaxel

    Drug

    Tislelizumab, Carboplatin, Paclitaxel

Treatment groups

574 Participants
are divided into 2 treatment groups
Group A: RC148 Plus Platinum-Based ChemotherapyExperimental treatment 1 intervention
Group B: Tislelizumab Plus Platinum-Based ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

PFS is assessed in accordance with RECIST v1.1

Time frame
24 months

Secondary outcomes

1

Overall Survival (OS)

OS

Time frame
24 months
2

PFS (assessed by the investigator(s))

PFS assessed by the investigator(s) is assessed in accordance with RECIST v1.1

Time frame
24 months
3

Objective Response Rate (ORR)

ORR is assessed in accordance with RECIST v1.1

Time frame
24 months
4

Duration of Response (DoR)

DoR is assessed in accordance with RECIST v1.1

Time frame
24 months

Other outcomes

Sponsors and contacts

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