Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic AlterationsPhase 3NCT07829549
Phase III Study of RC148 Plus Chemotherapy Versus Tislelizumab Plus Chemotherapy as First-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
A Phase 3 study testing RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection and Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection in people with Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic Alterations, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of RC148 plus platinum-based chemotherapy versus tislelizumab plus platinum-based chemotherapy in trial participants with previously untreated locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV), non-squamous non-small cell lung cancer without actionable genomic alterations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic Alterations
- What is being tested?
- RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection and Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to Aug 2031
- 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
- 1. Voluntarily agrees to participate in the study and provides written informed consent.
- 2. Willing and able to comply with study and follow-up procedures. 3. Male or female, aged 18 to 75 years inclusive. 4. Estimated life expectancy≥3 months. 5. ECOG performance status 0 or 1. 6. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not amenable to curative-intent therapy.
- 7. No prior systemic anti-tumor therapy for advanced or metastatic NSCLC 8. Has at least one measurable non-central nervous system lesion per RECIST v1.1.
- 9. Must provide PD-L1 expression testing report and actionable genomic alterations testing report before enrollment.
- 10. Adequate cardiac, bone marrow, hepatic, renal, and coagulation function. 11. Female study participants must be postmenopausal, surgically sterile, or, if of childbearing potential, must have a negative serum pregnancy test within 7 days prior to randomization, and agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 12 months after completion of study treatment. Female participants shall not donate ova or breastfeed during this period. Male study participants must agree to use at least one medically acceptable contraceptive method during study treatment and for 12 months after completion of study treatment, and shall not donate sperm during this period.
Who cannot join
- 1. Histologically confirmed presence of any squamous NSCLC, small cell carcinoma, neuroendocrine carcinoma, or sarcoma components.
- 2. Known actionable gene alterations positive or harboring gene mutations with approved first-line treatment options.
- 3. Presence of active brain metastases. 4. Screening imaging demonstrates marked tumor necrosis or cavitation, and the investigator determines that enrollment in this study may confer a risk of bleeding.
- 5. Have received chest radiotherapy >30 Gy within 6 months prior to randomization; received palliative local therapy for non-target lesions within 2 weeks prior to randomization; received non-specific immunomodulatory therapy within 2 weeks prior to randomization; or received Chinese herbal or proprietary medicines with anti-tumor indications within 1 week prior to randomization.
- 6. Have received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other therapy targeting anti-tumor immune mechanisms.
- 7. Have received other systemic anti-tumor therapy other than chemotherapy and PD-1/PD-L1 antibodies.
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- 8. Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks prior to randomization.
- 9. Have received any live or live-attenuated vaccine within 4 weeks prior to randomization, or plans to receive any live or live-attenuated vaccine during the study.
- 10. Participation in another clinical trial within 4 weeks prior to randomization 11. Have undergone major surgery, interventional therapy, or severe trauma within 4 weeks prior to randomization, or plans to undergo major surgery during the study period; has undergone core needle biopsy or other minor surgical procedures within 7 days prior to randomization.
- 12. Have a history of severe coagulation disorder, or is receiving anticoagulant medications, including those using prophylactic-dose anticoagulants.
- 13. Toxicities of prior anti-tumor therapy have not recovered to Grade 0-1 per CTCAE v6.0, excluding alopecia, pigmentation, expected irreversible endocrine toxicities secondary to prior immunotherapy that are stably controlled with medications, and other conditions judged by the investigator not to interfere with study drug treatment.
- 14. For participants with prior PD-1/PD-L1 inhibitor exposure: prior Grade ≥3 irAEs, irAEs resulting in permanent treatment discontinuation, Grade 2 immune-related cardiac irAEs, or any-grade neurologic or ocular irAEs; prior adverse events requiring immunosuppressants other than corticosteroids, or recurrent adverse events during prior immunotherapy requiring re-administration of systemic corticosteroids.
- 15. Have severe acute or chronic infection. 16. Occurrence of hemoptysis, active gastrointestinal bleeding, peptic ulcer, epistaxis, or other bleeding events requiring intervention within 4 weeks prior to randomization, or presence of severe esophagogastric varices, vasculitis, aneurysm, or dissection assessed by the investigator as high bleeding risk.
- 17. Serious arterial/venous thromboembolic events, cerebrovascular accident, or hypertensive encephalopathy occurring within 6 months prior to randomization.
- 18. Have active or clinically significant cardiac disease. 19. Previous and/or current interstitial lung disease, drug-related pneumonitis, radiation pneumonitis, severely impaired pulmonary function, acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to randomization, or clinical signs or high-risk factors suggestive of interstitial lung disease.
- 20. Have a history of gastrointestinal perforation and/or fistula, or gastrointestinal obstruction within 6 months prior to randomization.
- 21. Presence of systemic diseases assessed by the investigator as not stably controlled.
- 22. Presence of active autoimmune disease, or prior autoimmune disease at risk of recurrence.
- 23. Have a history of other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- 24. Have known hypersensitivity or delayed-type hypersensitivity reactions to any components of the study drug or analogous drugs.
- 25. Presence of symptomatic third-space effusion or third-space effusion requiring intervention.
- 26. Other malignancy within 5 years before initiation of study treatment. 27. Poor compliance and anticipated inability to comply with trial procedures 28. Previous or current presence of any other disease. 29. Non-malignant local or systemic disorders, or tumor-secondary diseases or symptoms associated with high medical risk and/or uncertainty in survival evaluation, e.g., cachexia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Multicenter Phase III Study of RC148 Combined With Platinum-Based Chemotherapy Versus Tislelizumab Combined With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
To evaluate the efficacy and safety of RC148 plus platinum-based chemotherapy versus tislelizumab plus platinum-based chemotherapy in trial participants with previously untreated locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV), non-squamous non-small cell lung cancer without actionable genomic alterations.
- Being tested
- RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection, Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin InjectionDrug
RC148, Pemetrexed Disodium, Carboplatin
Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin InjectionDrug
Tislelizumab, Pemetrexed Disodium, Carboplatin
| Study group | Role | What they receive |
|---|---|---|
| RC148 plus platinum-based chemotherapy | Experimental | Not described Receives: Drug: RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection |
| Tislelizumab plus platinum-based chemotherapy | Active comparator | Not described Receives: Drug: Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival assessed by BIRC per RECIST v1.1
Measured: 24 months
Secondary outcomes (12)
Overall Survival
Measured: 24 months
Objective Response Rate assessed by BIRC per RECIST v1.1
Measured: 24 months
Duration of Response assessed by BIRC per RECIST v1.1
Measured: 24 months
Disease Control Rate assessed by BIRC per RECIST v1.1
Measured: 24 months
Time To Response assessed by BIRC per RECIST v1.1
Measured: 24 months
Progression-Free Survival assessed by Investigator per RECIST v1.1
Measured: 24 months
Objective Response Rate assessed by Investigator per RECIST v1.1
Measured: 24 months
Duration of Response assessed by Investigator per RECIST v1.1
Measured: 24 months
Disease Control Rate assessed by Investigator per RECIST v1.1
Measured: 24 months
Time To Response assessed by Investigator per RECIST v1.1
Measured: 24 months
Number of participants with adverse events as assessed by CTCAE v6.0 during treatment
Measured: 24 months
Observed serum concentrations of RC148
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 posted21 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic AlterationsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829549
- Sponsor's protocol ID
- RC148-C304
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Phase III Study of RC148 Combined With Platinum-Based Chemotherapy Versus Tislelizumab Combined With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
- ClinicalTrials.gov ID
- NCT07829549
- Acronym / sponsor ID
- RC148-C304
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 21 Sep 2026 (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.
To evaluate the efficacy and safety of RC148 plus platinum-based chemotherapy versus tislelizumab plus platinum-based chemotherapy in trial participants with previously untreated locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV), non-squamous non-small cell lung cancer without actionable genomic alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC148 plus platinum-based chemotherapy | Experimental | Drug: RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection |
| Tislelizumab plus platinum-based chemotherapy | Active comparator | Drug: Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Voluntarily agrees to participate in the study and provides written informed consent.
- 2. Willing and able to comply with study and follow-up procedures. 3. Male or female, aged 18 to 75 years inclusive. 4. Estimated life expectancy≥3 months. 5. ECOG performance status 0 or 1. 6. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not amenable to curative-intent therapy.
- 7. No prior systemic anti-tumor therapy for advanced or metastatic NSCLC 8. Has at least one measurable non-central nervous system lesion per RECIST v1.1.
- 9. Must provide PD-L1 expression testing report and actionable genomic alterations testing report before enrollment.
- 10. Adequate cardiac, bone marrow, hepatic, renal, and coagulation function. 11. Female study participants must be postmenopausal, surgically sterile, or, if of childbearing potential, must have a negative serum pregnancy test within 7 days prior to randomization, and agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 12 months after completion of study treatment. Female participants shall not donate ova or breastfeed during this period. Male study participants must agree to use at least one medically acceptable contraceptive method during study treatment and for 12 months after completion of study treatment, and shall not donate sperm during this period.
Key exclusion criteria (22 listed)
- 1. Histologically confirmed presence of any squamous NSCLC, small cell carcinoma, neuroendocrine carcinoma, or sarcoma components.
- 2. Known actionable gene alterations positive or harboring gene mutations with approved first-line treatment options.
- 3. Presence of active brain metastases. 4. Screening imaging demonstrates marked tumor necrosis or cavitation, and the investigator determines that enrollment in this study may confer a risk of bleeding.
- 5. Have received chest radiotherapy >30 Gy within 6 months prior to randomization; received palliative local therapy for non-target lesions within 2 weeks prior to randomization; received non-specific immunomodulatory therapy within 2 weeks prior to randomization; or received Chinese herbal or proprietary medicines with anti-tumor indications within 1 week prior to randomization.
- 6. Have received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other therapy targeting anti-tumor immune mechanisms.
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 Injection plus Pemetrexed Disodium for Injection and Carboplatin InjectionRC148, Pemetrexed Disodium, Carboplatin | Drug | RC148 plus platinum-based chemotherapy |
| Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin InjectionTislelizumab, Pemetrexed Disodium, Carboplatin | Drug | Tislelizumab plus platinum-based chemotherapy |
Primary outcome
Progression-Free Survival assessed by BIRC per RECIST v1.1
Time frame: 24 months
12 secondary outcomes
Overall Survival
Time frame: 24 months
Objective Response Rate assessed by BIRC per RECIST v1.1
Time frame: 24 months
Duration of Response assessed by BIRC per RECIST v1.1
Time frame: 24 months
Disease Control Rate assessed by BIRC per RECIST v1.1
Time frame: 24 months
Time To Response assessed by BIRC per RECIST v1.1
Time frame: 24 months
Progression-Free Survival assessed by Investigator per RECIST v1.1
Time frame: 24 months
Objective Response Rate assessed by Investigator per RECIST v1.1
Time frame: 24 months
Duration of Response assessed by Investigator per RECIST v1.1
Time frame: 24 months
Disease Control Rate assessed by Investigator per RECIST v1.1
Time frame: 24 months
Time To Response assessed by Investigator per RECIST v1.1
Time frame: 24 months
Number of participants with adverse events as assessed by CTCAE v6.0 during treatment
Time frame: 24 months
Observed serum concentrations 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 22 Sep 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection and Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection in people with Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic Alterations, run by RemeGen Co., Ltd. at 1 site 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 5 inclusion and 22 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 assessed by BIRC per RECIST v1.1 (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 22 Sep 2026.