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Phase III Study of RC148 Plus Chemotherapy Versus Tislelizumab Plus Chemotherapy as First-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

ConditionPreviously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic Alterations
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

To evaluate the efficacy and safety of RC148 plus platinum-based chemotherapy versus tislelizumab plus platinum-based chemotherapy in trial participants with previously untreated locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV), non-squamous non-small cell lung cancer without actionable genomic alterations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Voluntarily agrees to participate in the study and provides written informed consent.

Disqualifiers

1. Histologically confirmed presence of any squamous NSCLC, small cell carcinoma, neuroendocrine carcinoma, or sarcoma components.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection

    Drug

    RC148, Pemetrexed Disodium, Carboplatin

  • Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection

    Drug

    Tislelizumab, Pemetrexed Disodium, Carboplatin

Treatment groups

540 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 assessed by BIRC per RECIST v1.1

Time frame
24 months

Secondary outcomes

1

Overall Survival

Time frame
24 months
2

Objective Response Rate assessed by BIRC per RECIST v1.1

Time frame
24 months
3

Duration of Response assessed by BIRC per RECIST v1.1

Time frame
24 months
4

Disease Control Rate assessed by BIRC per RECIST v1.1

Time frame
24 months

Other outcomes

Sponsors and contacts

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

RemeGen Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: