A Phase 3 interventional study of RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection and Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection in Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic Alterations, sponsored by RemeGen Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by RemeGen Co., Ltd. · Phase 3, Interventional, and Treatment
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.
RemeGen Co., Ltd. is the lead sponsor of 81 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Voluntarily agrees to participate in the study and provides written .
2. Willing and able to comply with study and follow-up procedures. 3. Male or female, aged 18 to 75 years inclusive. 4. Estimated ≥3 months. 5. performance status 0 or 1. 6. or cytologically confirmed locally advanced or 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 v1.1.
9. Must provide 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 , surgically sterile, or, if of , must have a negative serum pregnancy test within 7 days prior to randomization, and agree to use at least one medically acceptable 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.
Exclusion Criteria:
1. 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 treatment options.
3. Presence of active . 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 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.
8. Systemic treatment with or other drugs within 2 weeks prior to randomization.
9. Have received any live or 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 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 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 cardiac disease. 19. Previous and/or current interstitial lung disease, drug-related pneumonitis, radiation pneumonitis, severely impaired pulmonary function, acute exacerbation of 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 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 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection
Drug: Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection
Drug pages: RC148 · Pemetrexed · Carboplatin
RC148, Pemetrexed Disodium, Carboplatin
Drug pages: Tislelizumab · Pemetrexed · Carboplatin
Tislelizumab, Pemetrexed Disodium, Carboplatin
Progression-Free Survival assessed by BIRC per RECIST v1.1
Time frame: 24 months
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
Start is estimated for Sep 2026; primary completion for Apr 2031, 55 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: RC148 · Pemetrexed · Carboplatin