A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC
NCT ID: NCT06883630
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
120 participants
INTERVENTIONAL
2025-03-13
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AGA-, NSCLC without systemic therapy
Combination Therapy
RC148 plus Carboplatin and Paclitaxel/pemetrexed
RC148; Carboplatin; Paclitaxel; pemetrexed
AGA-，PD-1+, NSCLC without systemic therapy
Monotherapy
RC148
RC148 Monotherapy
EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment
Combination Therapy
RC148 plus Carboplatin and Paclitaxel/pemetrexed
RC148; Carboplatin; Paclitaxel; pemetrexed
Interventions
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RC148 plus Carboplatin and Paclitaxel/pemetrexed
RC148; Carboplatin; Paclitaxel; pemetrexed
RC148
RC148 Monotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be willing to and able to act on the trial and the follow up procedures;
3. Male or female, aged 18-80 years;
4. Expected survival ≥ 3 months;
5. ECOG PS score 0 or 1;
6. 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.
Exclusion Criteria
2. Received major surgeries and still in recovery within 28 days before the first dose;
3. 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);
4. 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;
5. Participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose;
6. Poor compliance and unable to complete the study procedures as assessed by investigator;
7. 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.
18 Years
80 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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li zhang
Role: STUDY_DIRECTOR
Sun Yat-sen University
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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RC148-C002
Identifier Type: -
Identifier Source: org_study_id
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