Non-Small Cell Lung CancerPhase 1NCT06883630
A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC
A Phase 1 study testing RC148 plus Carboplatin and Paclitaxel/pemetrexed and RC148 in people with Non-Small Cell Lung Cancer, run by RemeGen Co., Ltd. at 24 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- RC148 plus Carboplatin and Paclitaxel/pemetrexed and RC148
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 24 sitesChina
- Study dates
- 13 Mar 2025to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Beijing Tiantan Hospital of Capital Medical University
Beijing, Beijing Municipality
Peking University Cancer Hospital
Beijing, Beijing Municipality
Binzhou Medical University Hospital
Binzhou, Shandong
Hunan Cancer Hospital
Changsha, Hunan
Shunde Hospital of Southern Medical University
Foshan, Guangdong
The First People's Hospital of Shunde
Foshan, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
The First affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The Second Affiliated Hospital of Guilin Medical College
Gulin, Guangxi
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Nanyang Second General Hospital
Hanyang, Henan
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Jiangmen Central Hospital
Jiangmen, Guangdong
Jinan Central Hospital
Jinan, Shandong
Yunnan Cancer Hospital
Kunming, Yunnan
Linyi Cancer Hospital
Linyi, Shandong
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Tianjin Medical University Cancer Institute Hospital
Tianjin, Tianjin Municipality
Union Hospital Tongji Medical College Huazhong University Of Science And Technologe
Wuhan, Hubei
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Henan cancer hospital
Zhengzhou, Henan
About this study
Official title: 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.
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
Read the detailed description
Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- RC148 plus Carboplatin and Paclitaxel/pemetrexed, RC148
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC148 plus Carboplatin and Paclitaxel/pemetrexedDrug
Also called RC148 Injection
RC148; Carboplatin; Paclitaxel; pemetrexed
RC148Drug
Also called RC148 Injection
RC148 Monotherapy
| Study group | Role | What they receive |
|---|---|---|
| AGA-, NSCLC without systemic therapy | Experimental | Combination Therapy Receives: Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexed |
| AGA-，PD-1+, NSCLC without systemic therapy | Experimental | Monotherapy Receives: Drug: RC148 |
| EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment | Experimental | Combination Therapy Receives: Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (7)
Disease Control Rate (DCR)
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.
Measured: 24 months
Duration of Response (DOR)
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.
Measured: 24 months
Progression-free survival (PFS)
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.
Measured: 24 months
Overall survival (OS)
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.
Measured: 24 months
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: 24 months
Incidence of RC148 anti-drug antibody (ADA)
Serum samples will be collected from participants for ADA analysis of RC148. The blood sampling time points and time windows are described in protocol
Measured: 24 months
Maximum observed concentration (Cmax) of RC148
Serum concentrations of RC148 in individual subjects at different time points after RC148 administration
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start13 Mar 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- li zhang, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883630
- Sponsor's protocol ID
- RC148-C002
- Status last verified
- Jul 2025
- First submitted
- 5 Mar 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06883630
- Acronym / sponsor ID
- RC148-C002
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGA-, NSCLC without systemic therapy | Experimental | Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexedCombination Therapy |
| AGA-，PD-1+, NSCLC without systemic therapy | Experimental | Drug: RC148Monotherapy |
| EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment | Experimental | Drug: RC148 plus Carboplatin and Paclitaxel/pemetrexedCombination Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC148 plus Carboplatin and Paclitaxel/pemetrexedAlso: RC148 InjectionRC148; Carboplatin; Paclitaxel; pemetrexed | Drug | AGA-, NSCLC without systemic therapy, EGFR mu, Non-squamous NSCLC after EGFR-TKIs treatment |
| RC148Also: RC148 InjectionRC148 Monotherapy | Drug | AGA-，PD-1+, NSCLC without systemic therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: 24 months
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.
7 secondary outcomes
Disease Control Rate (DCR)
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Number of participants with adverse events (AEs)
Time frame: 24 months
Incidence of RC148 anti-drug antibody (ADA)
Time frame: 24 months
Maximum observed concentration (Cmax) of RC148
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li zhang study director
Sun Yat-sen University
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RC148 plus Carboplatin and Paclitaxel/pemetrexed and RC148 in people with Non-Small Cell Lung Cancer, run by RemeGen Co., Ltd. at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.