> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-phase-ib-study-of-rc148-as-monotherapy-or-combination-for-6c859f78-23ba-4da3-860d-35b24d9f759b
> Record changed: 2026-11-04

# A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC

NCT06883630

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

Participants

121

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

Lead sponsor

RemeGen Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

Start date

2025-03-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

Number of sites

24

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Title and summary

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Short title**

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Status and phase

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Dates

**Completion date**

2027-07-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**First posted**

2025-03-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Registry last updated**

2026-03-05

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Primary completion date**

2026-08-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Start date**

2025-03-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Size and sites

**Actual participants**

121

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Participants**

121

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Number of sites**

24

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Sponsor and oversight

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Lead sponsor**

RemeGen Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Identifiers

**Registry ID**

NCT06883630

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**ClinicalTrials.gov ID**

NCT06883630

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Single masking

**Masked roles**

Participants

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Outcomes

### Primary outcomes

1. Objective Response Rate (ORR)  
Timeframe: 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.

### Secondary outcomes

1. Disease Control Rate (DCR)  
Timeframe: 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.
2. Duration of Response (DOR)  
Timeframe: 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.
3. Progression-free survival (PFS)  
Timeframe: 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.
4. Overall survival (OS)  
Timeframe: 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.
5. Number of participants with adverse events (AEs)  
Timeframe: 24 months  
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.
6. Incidence of RC148 anti-drug antibody (ADA)  
Timeframe: 24 months  
Serum samples will be collected from participants for ADA analysis of RC148\. The blood sampling time points and time windows are described in protocol
7. Maximum observed concentration (Cmax) of RC148  
Timeframe: 24 months  
Serum concentrations of RC148 in individual subjects at different time points after RC148 administration

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

80 Years

**Healthy volunteers**

No

### Inclusion criteria

1. Voluntarily participate in the study and signed the ICF;
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

1. Histopathologically or cytologically confirmed small cell lung cancer;
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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Sites

- Beijing Tiantan Hospital of Capital Medical UniversityBeijing, China
- Peking University Cancer HospitalBeijing, China
- Shunde Hospital of Southern Medical UniversityFoshan, China
- The First People's Hospital of ShundeFoshan, China
- Sun Yat-sen University Cancer CenterGuangzhou, China
- The First affiliated Hospital of Guangzhou Medical UniversityGuangzhou, China
- Jiangmen Central HospitalJiangmen, China
- The Second Affiliated Hospital of Guilin Medical CollegeGulin, China
- Affiliated Cancer Hospital of Guangxi Medical UniversityNanning, China
- Harbin Medical University Cancer HospitalHarbin, China
- Nanyang Second General HospitalHanyang, China
- The First Affiliated Hospital of Xinxiang Medical CollegeXinxiang, China
- Henan cancer hospitalZhengzhou, China
- Union Hospital Tongji Medical College Huazhong University Of Science And TechnologeWuhan, China
- Hunan Cancer HospitalChangsha, China
- The Affiliated Hospital of Xuzhou Medical UniversityXuzhou, China
- Shengjing Hospital of China Medical UniversityShenyang, China
- Binzhou Medical University HospitalBinzhou, China
- Jinan Central HospitalJinan, China
- Linyi Cancer HospitalLinyi, China
- Tianjin Medical University Cancer Institute HospitalTianjin, China
- Yunnan Cancer HospitalKunming, China
- Zhejiang Cancer HospitalHangzhou, China
- Taizhou Hospital of Zhejiang ProvinceTaizhou, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883630)

## Related records

### Drugs (3)

- [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md)
- [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md)
- [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md)

### Lead sponsors (1)

- [RemeGen Co., Ltd.](https://trialight.com/data/company/remegen-co-ltd-aa4de0bf-d48b-4d78-b253-699b0bfdd564.md)

### Conditions (1)

- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition

### Targets (19)

- [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md)
- [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md)
- [NR1I2](https://trialight.com/data/target/nr1i2-40bab506-b45a-5acc-acc5-9834cb940ee5.md)
- [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md)
- [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md)
- [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md)
- [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md)
- [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md)
- [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md)
- [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md)
- [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md)
- [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md)
- [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md)
- [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md)
- [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md)
- [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md)
- [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md)
- [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md)
- [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md)

---

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