A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC
A Phase Ib, Multi-Cohort, Open-Label, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of RC148 Injection as Monotherapy or Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.
1 other identifier
interventional
121
1 country
24
Brief Summary
This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 nonsmall-cell-lung-cancer
Started Mar 2025
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2025
CompletedStudy Start
First participant enrolled
March 13, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
March 5, 2026
July 1, 2025
1.5 years
March 5, 2025
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
24 months
Secondary Outcomes (7)
Disease Control Rate (DCR)
24 months
Duration of Response (DOR)
24 months
Progression-free survival (PFS)
24 months
Overall survival (OS)
24 months
Number of participants with adverse events (AEs)
24 months
- +2 more secondary outcomes
Study Arms (3)
AGA-, NSCLC without systemic therapy
EXPERIMENTALCombination Therapy
AGA-，PD-1+, NSCLC without systemic therapy
EXPERIMENTALMonotherapy
EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment
EXPERIMENTALCombination Therapy
Interventions
RC148; Carboplatin; Paclitaxel; pemetrexed
Eligibility Criteria
You may qualify if:
- Voluntarily participate in the study and signed the ICF;
- Be willing to and able to act on the trial and the follow up procedures;
- Male or female, aged 18-80 years;
- Expected survival ≥ 3 months;
- ECOG PS score 0 or 1;
- All participants to be enrolled in cohorts 1-5 must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced or metastatic NSCLC (stage IIIB//IIIC/IV according to the 8th edition of UICC/AJCC) and not amendable to curative surgery or radiation as assessed by investigator.
You may not qualify if:
- Histopathologically or cytologically confirmed small cell lung cancer;
- Received major surgeries and still in recovery within 28 days before the first dose;
- Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study (except for COVID-19 vaccine);
- Received immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor treatment within 28 days prior to the first dose, or experienced prior permanent immunotherapy discontinuation due to immunotoxicity;
- Participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose;
- Poor compliance and unable to complete the study procedures as assessed by investigator;
- Have any other medical conditions, abnormal physical examinations or laboratory examinations that would be suspected interfere with participation or evaluation of the trial or increase the risk to the participant, in view of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Beijing Tiantan Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
The First People's Hospital of Shunde
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
The Second Affiliated Hospital of Guilin Medical College
Gulin, Guangxi, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Nanyang Second General Hospital
Hanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Henan cancer hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University Of Science And Technologe
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Tianjin Medical University Cancer Institute Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
li zhang
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2025
First Posted
March 19, 2025
Study Start
March 13, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
July 31, 2027
Last Updated
March 5, 2026
Record last verified: 2025-07