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Non-Small Cell Lung CancerPhase 3NCT07416474

RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)

A Phase 3 study testing RC148 plus Carboplatin and Paclitaxel and Tislelizumab plus Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by RemeGen Co., Ltd. at 78 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
RC148 plus Carboplatin and Paclitaxel and Tislelizumab plus Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
574 participants
Where
78 sitesChina
Study dates
3 Apr 2026to 30 Nov 2029
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the study and signed the Informed Consent Form (ICF).
  • Be willing to and able to participate in the trial and comply with the follow up procedures;
  • Male or female, aged 18-75 years.
  • Expected survival ≥ 3 months.
  • ECOG PS score 0 or 1.
  • Histopathologically or cytologically confirmed locally advanced or metastatic NSCLC not eligible for curative treatment.
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  • No prior systemic anti-tumor treatment for advanced or metastatic squamous NSCLC.
  • Sufficient cardiac, bone marrow, hepatic, renal, and coagulation function.
  • Female participants must be postmenopausal, surgically sterilized, or of childbearing potential with a negative blood pregnancy test within 7 days before the first dose. Female participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate oocytes or breastfeed during this period. Male participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate sperm during this period.
  • At least one measurable lesion outside of the brain according to the RECIST v1.1 criteria.
  • A PD-L1 expression test report that meets the requirements must be provided before enrollment.

Who cannot join

  • Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer.
  • Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist.
  • Presence of active brain metastases.
  • Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk.
  • Chest radiotherapy > 30Gy within 6 months before randomization; palliative local treatment for non-target lesions within 2 weeks before randomization; non-specific immunomodulatory treatment within 2 weeks before randomization; Chinese herbal medicine or proprietary Chinese medicine treatment with anti-tumor indications within 1 week before randomization.
  • History of immunotherapy. Note: For adjuvant/neoadjuvant phases or curative radiotherapy/chemoradiotherapy, PD-L1/PD-1 antibody therapy should be administered only if recurrence or metastasis occurs more than 12 months after the completion of the last medication.
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  • Prior systemic anti-tumor treatment other than chemotherapy and PD-1/PD-L1 antibodies.
  • Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks before randomization.
  • Use of any live or attenuated live vaccines within 4 weeks before randomization, or planned during the study.
  • Participation in other clinical trials within 4 weeks before randomization.
  • Major surgery, interventional therapy, or severe trauma within 4 weeks before randomization, or planned major surgery during the study; core needle biopsy or other minor surgery within 7 days before randomization.
  • Participants with history of severe coagulation dysfunction or current intake of anticoagulant drugs.
  • Toxic reactions from prior anti-tumor treatment have not recovered to grade 0-1 as defined by CTCAE version 6.0.
  • Severe acute or chronic infections.
  • Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 4 weeks before randomization; or presence of severe esophagogastric varices or epistaxis.
  • Severe arterial/venous thrombotic events or cerebrovascular accidents within 6 months before randomization.
  • Active or clinically significant heart disease.
  • Past or current interstitial lung disease, drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or clinical manifestations or high-risk factors suspected of interstitial lung disease.
  • History of gastrointestinal perforation and/or fistula, history of gastrointestinal obstruction within 6 months before randomization.
  • Presence of systemically diseases that are not stably controlled as judged by the investigator.
  • Active or history of autoimmune diseases with potential for recurrence.
  • Past history of other acquired or congenital immunodeficiency diseases or organ transplantation.
  • Known hypersensitivity or delayed-type hypersensitivity to certain components of the study drug or similar drugs.
  • Presence of symptomatic or intervention-requiring third-space effusions.
  • Other malignant tumors within 5 years before the start of study drug administration, except for malignant tumors that are expected to be cured after treatment.
  • Poor compliance and expected inability to cooperate with the completion of trial procedures.
  • Past or current history of any other diseases, abnormal physical examination findings, or abnormal laboratory examination findings that, in the investigator's judgment, reasonably suggest that the participant has a disease or condition unsuitable for the use of the study drug.
  • Local or systemic diseases not caused by malignant tumors, or diseases or symptoms secondary to tumors.
  • For participants who have used PD-1/L1 inhibitors, prior occurrence of grade 3 or above irAE related to immunotherapy, irAE leading to permanent discontinuation of treatment, grade 2 immune-related cardiotoxicity, or irAE of any grade involving the nervous system or eyes; prior occurrence of adverse events requiring treatment with immunosuppressive drugs other than corticosteroids, or recurrence of adverse events during previous immunotherapy requiring systemic use of corticosteroids again.

Trial locations and contacts

78 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yongfeng Yang contact

010-65384976

yongfeng.yang@remegen.com

78 sites in 1 country

China78 sites, 78 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan

    Recruiting

  • Affiliated Hospital of Hebei University

    Baoding

    Recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality

    Recruiting

  • Peking Union Medical College Hospital

    Beijing

    Recruiting

  • Affiliated Hospital of Binzhou Medical University

    Binzhou, Shandong

    Recruiting

  • The First People's Hospital of Chenzhou City

    Binzhou

    Recruiting

  • Cangzhou Central Hospital

    Cangzhou

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Recruiting

  • Cancer Hospital Affiliated to Chongqing University

    Chongqing, Chongqing Municipality

    Recruiting

  • Chongqing Medical University First Affiliated Hospital

    Chongqing, Chongqing Municipality

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Recruiting

  • The Second Affiliated Hospital of Army Medical University of the Chinese People's Liberation Army

    Chongqing

    Recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Recruiting

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian

    Recruiting

  • Cancer Hospital Affiliated to Guangzhou Medical University

    Guangzhou, Guangdong

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Recruiting

  • Sun Yat-sen University First Affiliated Hospital

    Guangzhou, Guangdong

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangzhou

    Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

    Recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

    Recruiting

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Cancer Hospital Affiliated to Harbin Medical University

    Harbin, Heilongjiang

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan

    Recruiting

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

    Recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu

    Recruiting

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, Jiangsu

    Recruiting

  • Cancer Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Recruiting

  • Nanyang Second People's Hospital

    Nanyang, Henan

    Recruiting

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai Chest Hospital

    Shanghai

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Recruiting

  • The Fourth Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Recruiting

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin

    Recruiting

  • Affiliated Cancer Hospital of Xinjiang University

    Ürümqi, Xinjiang

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Recruiting

  • Hubei Cancer Hospital

    Wuhan

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technolo

    Wuhan

    Recruiting

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu

    Recruiting

  • The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army

    Xi'an, Shaanxi

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

    Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Recruiting

  • The First Affiliated Hospital of Zhengzhou

    Zhengzhou, Henan

    Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong

    Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou

    Recruiting

Other trials in China

About this study

Official title: Randomized, Double-Blind, Multicenter Phase III Study of RC148 in Combination With Platinum-Based Chemotherapy Versus Tislelizumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer

This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Participants will: Take RC148 or Tislelizumab combined with platinum-based chemotherapy until the end of the research.

Being tested
RC148 plus Carboplatin and Paclitaxel, Tislelizumab plus Carboplatin and Paclitaxel
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 PaclitaxelDrug

    Also called RC148 plus Platinum-Based Chemotherapy

    RC148, Carboplatin, Paclitaxel

  • Tislelizumab plus Carboplatin and PaclitaxelDrug

    Also called Tislelizumab plus Platinum-Based Chemotherapy

    Tislelizumab, Carboplatin, Paclitaxel

Study groups in NCT07416474
Study groupRoleWhat they receive
RC148 Plus Platinum-Based ChemotherapyExperimentalNot described
Receives: Drug: RC148 plus Carboplatin and Paclitaxel
Tislelizumab Plus Platinum-Based ChemotherapyActive comparatorNot described
Receives: Drug: Tislelizumab plus Carboplatin and Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is assessed in accordance with RECIST v1.1

    Measured: 24 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS

    Measured: 24 months

  2. PFS (assessed by the investigator(s))

    PFS assessed by the investigator(s) is assessed in accordance with RECIST v1.1

    Measured: 24 months

  3. Objective Response Rate (ORR)

    ORR is assessed in accordance with RECIST v1.1

    Measured: 24 months

  4. Duration of Response (DoR)

    DoR is assessed in accordance with RECIST v1.1

    Measured: 24 months

  5. Time to Response (TTR)

    TTR is assessed in accordance with RECIST v1.1

    Measured: 24 months

  6. Treatment-Emergent Adverse Event (TEAE)

    Adverse events during treatment

    Measured: 46 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start3 Apr 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
574 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07416474
Sponsor's protocol ID
RC148-C301
Status last verified
Jul 2026
First submitted
10 Feb 2026
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RC148 plus Carboplatin and Paclitaxel and Tislelizumab plus Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by RemeGen Co., Ltd. at 78 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 11 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Yongfeng Yang (010-65384976, yongfeng.yang@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07416474.

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 14 Jul 2026.

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