Non-Small Cell Lung CancerPhase 2NCT04777084
The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.
A Phase 2 study testing IBI318 in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
The study is a prospective multi-cohort clinical study. Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. 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?
- IBI318
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 25 Dec 2025
- Phase
- Phase 2
- 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
- Eligible subjects selected for this study must meet all of the following criteria:
- Sign written informed consent before implementing any trial-related procedures;
- Age ≥18 years old and ≤75 years old;
- No limit on the gender;
- Cohort A: histological or cytological confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8) without EGFR gene sensitive mutations, ALK gene fusion or ROS1 gene fusion confirmed by histological specimens, Relapse after failure of first-line anti-PD-1 /PD-L1 antibody therapy, as follows:
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- Only one anti-PD-1/PD-L1 antibody monotherapy or combination therapy is accepted in the advanced stage of the disease, and other immunotherapy is not allowed;
- Previous anti-PD-1/L1 antibody monotherapy or combination therapy has the best curative effect (according to RECIST 1.1 criteria) as partial remission, complete remission, or stable disease for ≥6 months (defined as within 6 months from the first medication) No disease progression has occurred);
- Disease progression confirmed by imaging studies occurred during or after the most recent treatment.
- Cohort B: histological or cytological confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8) with histologically confirmed EGFR-sensitive mutations or ALK fusion, Relapse after failure of anti-EGFR-TKI or ALK-TKI therapy, as follows:
- In patients with EGFR-tKI sensitive mutations, the specific history of previous EGFR-TKI treatment can be one of the following:
- There is no T790M mutation in 20 exon after the failure of previous one or two generations of EGFR-TKI (including gefitinib, erlotinib, icotinib and afatinib);
- The 20 exon T790M mutation occurred after the treatment failure of the first or second generation EGFR-TKI monotherapy (including gefitinib, erlotinib, icotinib, and afatinib, etc.), and disease progression recurred after treatment with osimertinib or other third generation EGFR-TKI;
- Failure of prior osimertinib or other third-generation EGFR-TKI therapy as first-line therapy (regardless of EGFR T790M mutation status);
- Those who are allowed to receive neoadjuvant/adjuvant targeted therapy in the early stage and develop drug resistance after subsequent adjuvant targeted therapy, and their drug resistance status meets one of the three requirements of appeal.
- For patients with ALK fusion NSCLC, disease progression should occur after adequate ALK-TKI treatment, and there is no opportunity for subsequent targeted therapy.
- Cohort C: Locally advanced NSCLC that is not suitable for radical surgery or radiotherapy, or that has relapsed without systematic treatment, or that has metastasized without systematic treatment and is negative for PD-L1 expression. Patients who have previously received neoadjuvant or adjuvant therapy can also receive neoadjuvant or adjuvant therapy (but neoadjuvant or adjuvant therapy is chemotherapy/radiotherapy, not immunotherapy), and the end of neoadjuvant/adjuvant therapy should be ≥6 months after tumor progression; If the pathological type is adenocarcinoma, the absence of EGFR-sensitive mutations or ALK fusion or ROS1 fusion should be confirmed. Negative expression of PD-L1 was defined as TPS <1% using 22C3 test.
- 5. According to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1 version), there is at least one imaging measurable lesion. The lesions located in the radiation field of the previous radiotherapy can be regarded as measurable lesions if the progress is confirmed; 6. Subjects with brain metastases asymptomatic or with stable symptoms after local treatment are allowed to be included in the group, as long as the subjects meet the following conditions:
- There are measurable lesions outside the central nervous system;
- no symptoms of the central nervous system or no worsening of symptoms within at least 2 weeks;
- No need for glucocorticoid therapy, or stop glucocorticoid therapy within 7 days before the first administration, or the dosage of glucocorticoid is stable and reduced to less than 10mg/day prednisone (or equivalent dose) within 7 days before the first administration ; 7. Subjects are allowed to receive palliative radiotherapy (including craniocerebral radiotherapy for symptomatic brain metastases), but the radiotherapy must be completed at least 1 week before enrollment, and the radiotherapy-related toxicity should be restored to less than or equal to 1 degree (CTCAE 5.0, except for hair loss).
- 8. ECOG score 0-1 points; 9. Expected survival time> 3 months; 10. Sufficient organ function, subjects need to meet the following laboratory indicators:
- The absolute value of neutrophils (ANC) ≥1.5x109/L when no granulocyte colony-stimulating factor is used in the past 14 days;
- In the case of no blood transfusion in the past 14 days, platelets ≥100×109/L;
- In the past 14 days without blood transfusion or erythropoietin, hemoglobin>9g/dL;
- Total bilirubin≤1.5×upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within ≤2.5×ULN (subjects with liver metastases are allowed to have ALT or AST ≤5×ULN);
- Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥50ml/min;
- Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN;
- Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group;
- Myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are judged by the investigator to be of no clinical significance are also allowed to be included in the group); 11. For female subjects of childbearing age, a urine or serum pregnancy test and the result should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; 12. If there is a risk of conception, all subjects (whether male or female) need to adopt a low annual failure rate during the entire treatment period until 120 days after the last study drug administration (or 180 days after the last study drug administration) Less than 1% of contraceptive measures; 13. Blood pressure can be adequately controlled with or without anti hypertensive medication, defined as blood pressure≤150/ 90 mm Hg, and blood pressure was under stable control within 1 week before randomization.
- 14. Patients must have recovered from toxicity or complications if they have previously received surgery or radiation > 30Gy.
Who cannot join
- Subjects who meet the following criteria cannot be selected for this study:
- The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
- There is imaging evidence of tumor voids, tumor inclusion or invasion of large vessels. In addition, the proximity of the tumor to the large blood duct should be considered and the risk of severe bleeding associated with tumor shrinkage/necrosis after lenvatinib treatment should be excluded. (The large vessels in the chest include the main pulmonary artery, left pulmonary artery, right pulmonary artery, 4 pulmonary veins, superior vena cava, inferior vena cava and aorta);
- To cohort A: subjects who have previously used anti-PD-1, PD-L1 or other immunotherapy and meet the following conditions:
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- The toxicity that caused permanent discontinuation occurred before the termination of immunotherapy;
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- Prior to the administration of the study drug, the toxicity of the previous immunotherapy has not recovered or has not recovered to level 0-1. Asymptomatic and stable control of endocrine toxicity level 2 with appropriate replacement therapy is allowed to enter the group;
- Adverse events that require additional immunosuppressive agents in addition to corticosteroids, or adverse events that still recur in the use of corticosteroids during previous immunotherapy.
- To cohort B and C: Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); Anti-pd-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 4. Have received the following treatments:
- Received systemic anti-tumor therapy within 2 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine with anti-tumor indications), etc.;
- Previously received lenvatinib, bevacizumab, anlotinib monotherapy, or in combination with anti-PD-1 / PD-L1 drugs
- Have received any investigational drug treatment within 4 weeks before treatment;
- Received large doses of immunosuppressive drugs within 4 weeks before treatment (systemic glucocorticoid exceeding 10mg/day prednisone or its equivalent dose);
- Received live attenuated vaccine within 4 weeks before treatment (or plan to receive live attenuated vaccine during the study period);
- Have received major surgery (such as open cavity, thoracotomy, or Kaifu surgery), or unhealed surgical wounds, ulcers or fractures within 4 weeks before treatment.
- 5. Clinically significant cardiovascular damage occurred within 12 months of the first dose of study treatment.
- 6. Gastrointestinal diseases that may affect oral absorption of study drugs. 7. Prior gastrointestinal or grade ≥3 non-gastrointestinal fistula. 8. A history of other malignancies is known, and unless the participant has undergone potentially curative treatment, there is no evidence of disease recurrence in the 3 years since the start of that treatment.
- 9. Severe allergy to IBI318 and lenvatinib. 10. There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included in the group); 11. Subjects who have received thoracic radiotherapy of greater than 30 Gy within 6 months before treatment or palliative radiotherapy of 30 Gy or less within 7 days before treatment (allowing palliative treatment of bone lesions or intracranial lesions) Radiation Therapy); 12. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 13. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14. Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or hair loss); 15. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 16. Untreated active hepatitis B (defined as HBsAg positive and the number of HBV-DNA copies detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center);
- Note: Hepatitis B subjects who meet the following criteria can also be included in the group:
- Before the first administration, the HBV viral load is less than 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation
- For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is no need to receive preventive anti-HBV treatment, but close monitoring of virus reactivation is required 17. Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection); 18. Live vaccines have been vaccinated within 30 days before the first administration (cycle 1, day 1); Note: It is allowed to receive inactivated virus vaccine for seasonal influenza injection within 30 days before the first administration; however, it is not allowed to receive live attenuated influenza vaccine for intranasal administration.
- 19. Pregnant or lactating women; 20. There are any serious or uncontrollable systemic diseases, such as:
- The resting electrocardiogram has major abnormalities in rhythm, conduction or morphology that are severe and difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation;
- Left ventricular ejection fraction (LVEF) was lower than normal; 3）QTc interval is extended to more than 480 ms；
- 4) Unstable angina pectoris, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) grade ≥ 2; 5) Myocardial infarction occurred within 6 months before enrollment; 6) A history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or current clinically active interstitial lung disease; 7) Active tuberculosis; 8) There is an active or uncontrolled infection that requires systemic treatment; 9) There is clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; 10) Liver diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 11) Poor control of diabetes (fasting blood glucose (FBG)> 10mmol/L); 12) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein quantification is confirmed to be greater than 1.0 g; 13) Subjects who have mental disorders and cannot cooperate with treatment; 21. The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subject from participating in the study, or the investigator believes that it is not suitable for inclusion this research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer hospital
Changsha, Hunan
Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn
About this study
Official title: A Prospective, Multi-cohort Clinical Research of Efficacy and Safety of Bispecific Anti-PD-1 / PD-L1 Antibody IBI318 Combined with Lenvatinib in the Treatment of Advanced NSCLC
The study is a prospective multi-cohort clinical study. Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation /ALK fusion after EGFR-TKI /ALK-TKI treatment resistance. Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type. After being screened to meet the inclusion criteria, they will receive IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan.
Read the detailed description
The study is a prospective multi-cohort clinical study. Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation /ALK fusion after EGFR-TKI /ALK-TKI treatment resistance. Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type.
After being screened to meet the inclusion criteria, they will receive IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan. During the treatment, RECIST v1.1 was used for clinical tumor imaging evaluation, once every 6 weeks; after 24 weeks of medication, evaluation can be done every 8 weeks.
Subjects receiving IBI318 combined with lenvatinib have the first evidence of imaging PD according to RECIST v1.1. If the subject is clinically stable, there is no evidence of rapid imaging progress, and the investigator assesses that it can continue from the study If the patient is benefited from the drug, the subject can continue the current study treatment, and the imaging evaluation must be repeated at least 6 weeks (± 7 days) later for confirmation. If PD is confirmed by re-assessment, the subject should stop the study treatment; if PD is not confirmed, the study treatment will continue, and the assessment will be carried out at the time point of the imaging examination plan specified in the plan until the PD is confirmed by imaging.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- IBI318
- 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.
IBI318Drug
IBI318, 300 mg, administered by intravenous infusion on the first day of each cycle, 1 cycle every 2 weeks (Q2W), continuous medication; lenvatinib 8 mg, orally, continued medication until disease progression, death, toxicity is intolerable, Withdrawal of informed consent, start a new anti-tumor treatment or terminate the treatment for other reasons specified in the plan, the maximum use time is 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. Receives: Drug: IBI318 |
| Cohort B | Experimental | Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation /ALK fusion after EGFR-TKI /ALK-TKI treatment resistance. Receives: Drug: IBI318 |
| Cohort C | Experimental | Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type. Receives: Drug: IBI318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 weeks ORR
Defined as the proportion of subjects achieving a complete remission (CR) or partial remission (PR) at around 12 weeks after the start of study treatment among all subjects.
Measured: 1 year
Secondary outcomes (6)
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Measured: 1 year
DCR
Defined as the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) to the total subjects
Measured: 1 year
DOR
Defined as the time interval from the first record of disease remission to disease progression or death (whichever occurs first)
Measured: 1 year
OS
Defined as the time from the start of treatment to the death of the subject due to any cause.
Measured: 1 year
BOR
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Measured: 1 year
adverse events (safety)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Aug 2021
- Primary completion30 Dec 2024
- Study completion25 Dec 2025 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777084
- Sponsor's protocol ID
- LIVE
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2021
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-cohort Clinical Research of Efficacy and Safety of Bispecific Anti-PD-1 / PD-L1 Antibody IBI318 Combined with Lenvatinib in the Treatment of Advanced NSCLC
- ClinicalTrials.gov ID
- NCT04777084
- Acronym / sponsor ID
- LIVE
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 2 Mar 2021 (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.
The study is a prospective multi-cohort clinical study. Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation /ALK fusion after EGFR-TKI /ALK-TKI treatment resistance. Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type. After being screened to meet the inclusion criteria, they will receive IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan.
Detailed description
The study is a prospective multi-cohort clinical study. Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation /ALK fusion after EGFR-TKI /ALK-TKI treatment resistance. Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type.
After being screened to meet the inclusion criteria, they will receive IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan. During the treatment, RECIST v1.1 was used for clinical tumor imaging evaluation, once every 6 weeks; after 24 weeks of medication, evaluation can be done every 8 weeks.
Subjects receiving IBI318 combined with lenvatinib have the first evidence of imaging PD according to RECIST v1.1. If the subject is clinically stable, there is no evidence of rapid imaging progress, and the investigator assesses that it can continue from the study If the patient is benefited from the drug, the subject can continue the current study treatment, and the imaging evaluation must be repeated at least 6 weeks (± 7 days) later for confirmation. If PD is confirmed by re-assessment, the subject should stop the study treatment; if PD is not confirmed, the study treatment will continue, and the assessment will be carried out at the time point of the imaging examination plan specified in the plan until the PD is confirmed by imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: IBI318Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1/PD-L1 inhibitor therapy. |
| Cohort B | Experimental | Drug: IBI318Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation /ALK fusion after EGFR-TKI /ALK-TKI treatment resistance. |
| Cohort C | Experimental | Drug: IBI318Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Eligible subjects selected for this study must meet all of the following criteria:
- <!-- -->
- Cohort B: histological or cytological confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8) with histologically confirmed EGFR-sensitive mutations or ALK fusion, Relapse after failure of anti-EGFR-TKI or ALK-TKI therapy, as follows:
- In patients with EGFR-tKI sensitive mutations, the specific history of previous EGFR-TKI treatment can be one of the following:
- There is no T790M mutation in 20 exon after the failure of previous one or two generations of EGFR-TKI (including gefitinib, erlotinib, icotinib and afatinib);
Key exclusion criteria (25 listed)
- Subjects who meet the following criteria cannot be selected for this study:
- <!-- -->
- To cohort B and C: Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); Anti-pd-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 4. Have received the following treatments:
- Received systemic anti-tumor therapy within 2 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine with anti-tumor indications), etc.;
- Previously received lenvatinib, bevacizumab, anlotinib monotherapy, or in combination with anti-PD-1 / PD-L1 drugs
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 |
|---|---|---|
| IBI318IBI318, 300 mg, administered by intravenous infusion on the first day of each cycle, 1 cycle every 2 weeks (Q2W), continuous medication; lenvatinib 8 mg, orally, continued medication until disease progression, death, toxicity is intolerable, Withdrawal of informed consent, start a new anti-tumor treatment or terminate the treatment for other reasons specified in the plan, the maximum use time is 2 years. | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
12 weeks ORR
Time frame: 1 year
Defined as the proportion of subjects achieving a complete remission (CR) or partial remission (PR) at around 12 weeks after the start of study treatment among all subjects.
6 secondary outcomes
PFS
Time frame: 1 year
DCR
Time frame: 1 year
DOR
Time frame: 1 year
OS
Time frame: 1 year
BOR
Time frame: 1 year
adverse events (safety)
Time frame: 1 year
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 2025.
- Individual participant dataSharing planned: No
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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.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI318 in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital 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 32 inclusion and 25 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 5 Mar 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yongchang Yongchang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 weeks ORR (time frame: 1 year). 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 2025.