Relapsed or Metastatic Non-small Cell Lung CancerPhase 1/2CT32NCT04797702
Glumetinib Combined With Toripalimab in the Treatment of Relapsed or Metastatic Non-small Cell Lung Cancer.
A Phase 1/2 study testing Glumetinib combined with Toripalimab in people with Relapsed or Metastatic Non-small Cell Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase Ib/II registration clinical study, consisting of two parts: the Phase Ib dose-climbing study and the Phase II efficacy exploration study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Glumetinib combined with Toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to 7 Nov 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Subsubjects with histologically or cytologically confirmed NSCLC, clinically diagnosed as locally advanced (stage IIIB or IIIC) and stage IV NSCLC (according to AJCC 8th edition staging), EGFR wild-type, negative for ALK and ROS1 rearrangement, and no Met exon14 skipping mutation; genetic testing is not mandatory for subjects with squamous cell cancer;
- PD - L1 expression of 1% or higher.
- Non-small cell lung cancer patients following failure of or were intolerance to previous standard treatment (chemotherapy and immunotherapy alone or in combination) and received no more than third-line treatment;
- At least 1 measurable tumor lesion according to RECIST1.1 criteria.
- Subjects must provide valid and qualified tissue samples (fresh biopsy or preserved tumor tissue samples are acceptable, but fresh biopsy samples are preferred).
- ECOG score ≤1 point;
- Sufficient function of bone marrow, liver and kidney organs.
Who cannot join
- Pathological diagnosis confirmed the presence of small cell lung cancer;
- The patient was currently participating in and receiving other studies or had previously received another c-Met inhibitor;
- There are mutations/rearrangements of EGFR, ALK, ROS1, Met14 exon skipping;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Open-label, Multi-center Phase Ib/II Clinical Study of Glumetinib Combined With Toripalimab in Patients With Relapsed or Metastatic Non-small Cell Lung Cancer Who Have Failed or Are Intolerant to Standard Therapy.
This is an open-label, multicenter Phase Ib/II registration clinical study, consisting of two parts: the Phase Ib dose-climbing study and the Phase II efficacy exploration study.
Phase Ib :
Read more
Phase Ib is a multicenter, single-arm study evaluating the safety, tolerability, and preliminary efficacy of SCC244 combined with Toripalimab in patients with advanced relapsed or metastatic non-small cell lung cancer who have failed standard therapy.At the start of the study, MTPI2 was used to guide toxicity monitoring and dose climbing in combination with Toripalimab (240mg intravenous every 3 weeks), with 5 subjects planned to be enrolled in each dose group.The SMC will decide whether to add the new dose level and sample size based on the latest study data available.The MTD or recommended phase II dose (RP2D) will be determined during the phase Ib study on the basis of the latest availablestudy data, and the phase II study will commence once the MTD or recommended phase II dose (RP2D) is confirmed.
Phase II:
Phase II is a multicenter, open-label, single-arm study evaluating the efficacy and safety of a recommended dose of glumetinib combined with Toripalimab in patients with relapsed, metastatic non-small cell lung cancer who have failed standard therapy.The SMC determined the dose group for the Phase II study based on the safety and initial efficacy data of the Phase Ib subjects.Approximately 62 evaluable subjects will be enrolled, with the recommended dose of glutmetinib once daily and Toripalimab 240mg every 3 weeks.
Every 21 days is a treatment cycle until the subject develops disease progression,intolerable toxicity, has used JS001 for 2 years, the informed consent is withdrawn, the investigator considers that the subject should not continue the medication, lost to follow-up, death occurs, or the study is terminated, whichever comes first.
- Being tested
- Glumetinib combined with Toripalimab
- Medical subject headings
- Recurrence, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glumetinib combined with ToripalimabCombination product
Ib：All enrolled subjects received Glumetinib combined with Toripalimab on a 21-day cycle, starting with 200mg/ day continuous Glumetinib and 240mg/ 3 weeks Toripalimab.
II：The SMC will determine the dose group for the Phase II study based on the safety and initial efficacy data of the Phase Ib subjects. Approximately 62 evaluable subjects will be enrolled in the study to receive the recommended dose of Glumetinib once daily and continuous treatment with Toripalimab 240mg every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Glumetinib combined with Toripalimab Receives: Combination Product: Glumetinib combined with Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The type, frequency, severity and outcome of adverse events (TEAE) and serious adverse events (SAE) that occurred during the treatment period. (Phase Ib)
The toxicity was evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) Grade.
Measured: 2 years
Number of prticipants with abnormal laboratory values and/or Adverse Events that are related to treatment. (Phase Ib)
Laboratory values include 1. Routine blood test: Including complete blood count with differential. 2.Routine urine test: including specific gravity, pH, urine glucose, protein, ketone bodies and blood cell. 3.Serum biochemistry: Including ALT, AST, ALP, TP, ALB, TBIL, DBIL, GLU, BUN/UREA, Cr, K+, Na+, Cl-, Ca2+, P, TG, TC, HDL, LDL, and AMY/LIP. 4.Coagulation function: Including at least international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT); if the international normalized ratio (INR) is not available, replace it with prothrombin time (PT). 5.Thyroid function test includes: serum thyroid stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4); if FT3 and FT4 are not available, replace them with T3 and T4. 6.Troponin I or troponin T content: only during the screening period and when clinical indications (such as cardiac events occur).
Measured: 2 years
Number of participants with abnormal vital signs values and/or Adverse Events that are related to treatment. (Phase Ib)
The vital signs include body temperature, heart rate, and respiratory frequency and blood pressure.
Measured: 2 years
Number of participants with abnormal ECG and echocardiography values /or Adverse Events that are related to treatment. (Phase Ib)
During the screening period, it is necessary to repeat the inspection three times before the first administration, with an interval of about 5 minutes between each time. Calculate the QTc interval and calculate the mean (corrected using Fridericia's formula). If the inspection time in the screening period is ≤ 7 days before the first administration, the review may not be necessary according to the judgment of the investigator. Check once a week in the 1st cycle of phase Ib, check once on the 1st and 15th days of the 2nd cycle, and check once every 3 weeks from the 3rd cycle. Use echocardiography or multi-gate angiography scan to check the left ventricular ejection fraction.
Measured: 2 years
Number of participants with aphysical examination values /or Adverse Events that are related to treatment.(Phase Ib)
A full physical examination in the screening period and at the end-of-treatment visit, including head, eyes, ears, nose, throat, neck, heart, chest (including lungs), abdomen, four limbs, skin, lymph nodes, nervous system, and subject's general condition. Body height and body weight are measured at the first visit, and then body weight is measured at each of the subsequent visits. Targeted physical examination will be conducted at other visits by the investigator.
Measured: 2 years
To determine the recommended dose for the phase II study (RP2D) .(Phase Ib)
Phase Ib is the dose-escalation period, and the optimal dose of Glumetinib combined with Toripalimab was explored as the recommended dose for the phase II clinical study.
Measured: 2 years
Investigator-assessed objective response rate (ORR) (Phase 2)
ORR refers to the percentage of subjects with confirmed CR or PR according to RECIST1.1
Measured: 2 years
Secondary outcomes (16)
Investigator-assessed objective response rate (ORR). (Phase 1b)
ORR refers to the percentage of subjects with confirmed CR or PR according to RECIST1.1 and iRECIST.
Measured: 2 years
Investigator-assessed progression-free survival (PFS) . (Phase 1b)
PFS means from the first use of the investigational product until disease progression or death, whichever occurs first, the disease progression will be evaluated by the investigator according to RECIST1.1 and iRECIST standards.
Measured: 2 years
Investigator-assessed duration of remission(DoR). (Phase 1b)
DoR is defined as the time from the first CR or PR assessment by the investigator according to the RECIST1.1 and iRECIST criteria to tumor progression or death from any cause, whichever occurs first.
Measured: 2 years
Investigator-assessed disease control rate (DCR). (Phase 1b)
It is defined as the percentage of the sum of CR, PR and disease stable for at least 4 weeks (SD≥4 weeks) evaluated by the investigator according to the RECIST1.1 and iRECIST standards.
Measured: 2 years
Investigator-assessed overall survival (OS) and 1-year OS rate.(Phase 1b)
OS defined as the time from the first use of the investigational product to death from any cause. 1-year OS rate defined as the proportion of subjects surviving within 1 year after the first dose.
Measured: 2 years
Investigator-assessed objective response rate (ORR). (Phase II)
ORR refers to the percentage of subjects with confirmed CR or PR according to RECIST1.1 and iRECIST.
Measured: 2 years
Investigator-assessed progression-free survival (PFS) . (Phase II)
PFS means from the first use of the investigational product until disease progression or death, whichever occurs first, the disease progression will be evaluated by the investigator according to RECIST1.1 and iRECIST standards.
Measured: 2 years
Investigator-assessed duration of remission(DoR). (Phase II)
DoR is defined as the time from the first CR or PR assessment by the investigator according to the RECIST1.1 and iRECIST criteria to tumor progression or death from any cause, whichever occurs first.
Measured: 2 years
Investigator-assessed disease control rate (DCR). (Phase II)
It is defined as the percentage of the sum of CR, PR and disease stable for at least 4 weeks (SD≥4 weeks) evaluated by the investigator according to the RECIST1.1 and iRECIST standards.
Measured: 2 years
Investigator-assessed overall survival (OS) and 1 year OS rate. (Phase II)
OS defined as the time from the first use of the investigational product to death from any cause. -year OS rate defined as the proportion of subjects surviving within 1 year after the first dose.
Measured: 2 years
The type, frequency, severity and outcome of adverse events (TEAE) and serious adverse events (SAE) that occurred during the treatment period. (Phase II)
The toxicity was evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) Grade.
Measured: 2 years
Number of prticipants with abnormal laboratory values and/or Adverse Events that are related to treatment. (Phase II)
The laboratory values include 1. Routine blood test: Including complete blood count with differential. 2.Routine urine test: including specific gravity, pH, urine glucose, protein, ketone bodies and blood cell. 3.Serum biochemistry: Including ALT, AST, ALP, TP, ALB, TBIL, DBIL, GLU, BUN/UREA, Cr, K+, Na+, Cl-, Ca2+, P, TG, TC, HDL, LDL, and AMY/LIP. 4.Coagulation function: Including at least international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT); if the international normalized ratio (INR) is not available, replace it with prothrombin time (PT). 5.Thyroid function test includes: serum thyroid stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4); if FT3 and FT4 are not available, replace them with T3 and T4. 6.Troponin I or troponin T content: only during the screening period and when clinical indications (such as cardiac events occur).
Measured: 2 years
Number of participants with abnormal vital signs values and/or Adverse Events that are related to treatment.(Phase II)
The vital signs include body temperature, heart rate, and respiratory frequency and blood pressure.
Measured: 2 years
Number of participants with abnormal ECG and echocardiography values /or Adverse Events that are related to treatment.(Phase II)
During the screening period, it is necessary to repeat the inspection three times before the first administration, with an interval of about 5 minutes between each time. Calculate the QTc interval and calculate the mean (corrected using Fridericia's formula). If the inspection time in the screening period is ≤ 7 days before the first administration, the review may not be necessary according to the judgment of the investigator. Check once a week in the 1st cycle of phase Ib, check once on the 1st and 15th days of the 2nd cycle, and check once every 3 weeks from the 3rd cycle. Use echocardiography or multi-gate angiography scan to check the left ventricular ejection fraction.
Measured: 2 years
Number of participants with aphysical examination values /or Adverse Events that are related to treatment.(Phase II)
A full physical examination in the screening period and at the end-of-treatment visit, including head, eyes, ears, nose, throat, neck, heart, chest (including lungs), abdomen, four limbs, skin, lymph nodes, nervous system, and subject's general condition. Body height and body weight are measured at the first visit, and then body weight is measured at each of the subsequent visits. Targeted physical examination will be conducted at other visits by the investigator.
Measured: 2 years
ORR in PD-L1 positive and negative populations.
Collect subjects' pathological sections for evaluation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start21 Apr 2021
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Why it stopped: The company's research strategy was adjusted and the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Metastatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797702
- Sponsor's protocol ID
- JS001-032-Ib/II-NSCLC
- Acronym
- CT32
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2021
- Last updated
- 29 Jul 2026
- Results posted
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Multi-center Phase Ib/II Clinical Study of Glumetinib Combined With Toripalimab in Patients With Relapsed or Metastatic Non-small Cell Lung Cancer Who Have Failed or Are Intolerant to Standard Therapy.
- ClinicalTrials.gov ID
- NCT04797702
- Acronym / sponsor ID
- CT32 / JS001-032-Ib/II-NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The company's research strategy was adjusted and the study was terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 15 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.
This is an open-label, multicenter Phase Ib/II registration clinical study, consisting of two parts: the Phase Ib dose-climbing study and the Phase II efficacy exploration study.
Phase Ib :
Phase Ib is a multicenter, single-arm study evaluating the safety, tolerability, and preliminary efficacy of SCC244 combined with Toripalimab in patients with advanced relapsed or metastatic non-small cell lung cancer who have failed standard therapy.At the start of the study, MTPI2 was used to guide toxicity monitoring and dose climbing in combination with Toripalimab (240mg intravenous every 3 weeks), with 5 subjects planned to be enrolled in each dose group.The SMC will decide whether to add the new dose level and sample size based on the latest study data available.The MTD or recommended phase II dose (RP2D) will be determined during the phase Ib study on the basis of the latest availablestudy data, and the phase II study will commence once the MTD or recommended phase II dose (RP2D) is confirmed.
Phase II:
Phase II is a multicenter, open-label, single-arm study evaluating the efficacy and safety of a recommended dose of glumetinib combined with Toripalimab in patients with relapsed, metastatic non-small cell lung cancer who have failed standard therapy.The SMC determined the dose group for the Phase II study based on the safety and initial efficacy data of the Phase Ib subjects.Approximately 62 evaluable subjects will be enrolled, with the recommended dose of glutmetinib once daily and Toripalimab 240mg every 3 weeks.
Every 21 days is a treatment cycle until the subject develops disease progression,intolerable toxicity, has used JS001 for 2 years, the informed consent is withdrawn, the investigator considers that the subject should not continue the medication, lost to follow-up, death occurs, or the study is terminated, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Combination Product: Glumetinib combined with ToripalimabGlumetinib combined with Toripalimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subsubjects with histologically or cytologically confirmed NSCLC, clinically diagnosed as locally advanced (stage IIIB or IIIC) and stage IV NSCLC (according to AJCC 8th edition staging), EGFR wild-type, negative for ALK and ROS1 rearrangement, and no Met exon14 skipping mutation; genetic testing is not mandatory for subjects with squamous cell cancer;
- PD - L1 expression of 1% or higher.
- Non-small cell lung cancer patients following failure of or were intolerance to previous standard treatment (chemotherapy and immunotherapy alone or in combination) and received no more than third-line treatment;
- At least 1 measurable tumor lesion according to RECIST1.1 criteria.
- Subjects must provide valid and qualified tissue samples (fresh biopsy or preserved tumor tissue samples are acceptable, but fresh biopsy samples are preferred).
Key exclusion criteria (3 listed)
- Pathological diagnosis confirmed the presence of small cell lung cancer;
- The patient was currently participating in and receiving other studies or had previously received another c-Met inhibitor;
- There are mutations/rearrangements of EGFR, ALK, ROS1, Met14 exon skipping;
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 |
|---|---|---|
| Glumetinib combined with ToripalimabIb：All enrolled subjects received Glumetinib combined with Toripalimab on a 21-day cycle, starting with 200mg/ day continuous Glumetinib and 240mg/ 3 weeks Toripalimab. II：The SMC will determine the dose group for the Phase II study based on the safety and initial efficacy data of the Phase Ib subjects. Approximately 62 evaluable subjects will be enrolled in the study to receive the recommended dose of Glumetinib once daily and continuous treatment with Toripalimab 240mg every 3 weeks. | Combination product | Experimental group |
Primary outcome
The type, frequency, severity and outcome of adverse events (TEAE) and serious adverse events (SAE) that occurred during the treatment period. (Phase Ib)
Time frame: 2 years
The toxicity was evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) Grade.
Number of prticipants with abnormal laboratory values and/or Adverse Events that are related to treatment. (Phase Ib)
Time frame: 2 years
Laboratory values include 1. Routine blood test: Including complete blood count with differential. 2.Routine urine test: including specific gravity, pH, urine glucose, protein, ketone bodies and blood cell. 3.Serum biochemistry: Including ALT, AST, ALP, TP, ALB, TBIL, DBIL, GLU, BUN/UREA, Cr, K+, Na+, Cl-, Ca2+, P, TG, TC, HDL, LDL, and AMY/LIP. 4.Coagulation function: Including at least international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT); if the international normalized ratio (INR) is not available, replace it with prothrombin time (PT). 5.Thyroid function test includes: serum thyroid stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4); if FT3 and FT4 are not available, replace them with T3 and T4. 6.Troponin I or troponin T content: only during the screening period and when clinical indications (such as cardiac events occur).
Number of participants with abnormal vital signs values and/or Adverse Events that are related to treatment. (Phase Ib)
Time frame: 2 years
The vital signs include body temperature, heart rate, and respiratory frequency and blood pressure.
Number of participants with abnormal ECG and echocardiography values /or Adverse Events that are related to treatment. (Phase Ib)
Time frame: 2 years
During the screening period, it is necessary to repeat the inspection three times before the first administration, with an interval of about 5 minutes between each time. Calculate the QTc interval and calculate the mean (corrected using Fridericia's formula). If the inspection time in the screening period is ≤ 7 days before the first administration, the review may not be necessary according to the judgment of the investigator. Check once a week in the 1st cycle of phase Ib, check once on the 1st and 15th days of the 2nd cycle, and check once every 3 weeks from the 3rd cycle. Use echocardiography or multi-gate angiography scan to check the left ventricular ejection fraction.
Number of participants with aphysical examination values /or Adverse Events that are related to treatment.(Phase Ib)
Time frame: 2 years
A full physical examination in the screening period and at the end-of-treatment visit, including head, eyes, ears, nose, throat, neck, heart, chest (including lungs), abdomen, four limbs, skin, lymph nodes, nervous system, and subject's general condition. Body height and body weight are measured at the first visit, and then body weight is measured at each of the subsequent visits. Targeted physical examination will be conducted at other visits by the investigator.
To determine the recommended dose for the phase II study (RP2D) .(Phase Ib)
Time frame: 2 years
Phase Ib is the dose-escalation period, and the optimal dose of Glumetinib combined with Toripalimab was explored as the recommended dose for the phase II clinical study.
Investigator-assessed objective response rate (ORR) (Phase 2)
Time frame: 2 years
ORR refers to the percentage of subjects with confirmed CR or PR according to RECIST1.1
16 secondary outcomes
Investigator-assessed objective response rate (ORR). (Phase 1b)
Time frame: 2 years
Investigator-assessed progression-free survival (PFS) . (Phase 1b)
Time frame: 2 years
Investigator-assessed duration of remission(DoR). (Phase 1b)
Time frame: 2 years
Investigator-assessed disease control rate (DCR). (Phase 1b)
Time frame: 2 years
Investigator-assessed overall survival (OS) and 1-year OS rate.(Phase 1b)
Time frame: 2 years
Investigator-assessed objective response rate (ORR). (Phase II)
Time frame: 2 years
Investigator-assessed progression-free survival (PFS) . (Phase II)
Time frame: 2 years
Investigator-assessed duration of remission(DoR). (Phase II)
Time frame: 2 years
Investigator-assessed disease control rate (DCR). (Phase II)
Time frame: 2 years
Investigator-assessed overall survival (OS) and 1 year OS rate. (Phase II)
Time frame: 2 years
The type, frequency, severity and outcome of adverse events (TEAE) and serious adverse events (SAE) that occurred during the treatment period. (Phase II)
Time frame: 2 years
Number of prticipants with abnormal laboratory values and/or Adverse Events that are related to treatment. (Phase II)
Time frame: 2 years
Number of participants with abnormal vital signs values and/or Adverse Events that are related to treatment.(Phase II)
Time frame: 2 years
Number of participants with abnormal ECG and echocardiography values /or Adverse Events that are related to treatment.(Phase II)
Time frame: 2 years
Number of participants with aphysical examination values /or Adverse Events that are related to treatment.(Phase II)
Time frame: 2 years
ORR in PD-L1 positive and negative populations.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The company's research strategy was adjusted and the study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glumetinib combined with Toripalimab in people with Relapsed or Metastatic Non-small Cell Lung Cancer, run by Shanghai Junshi Bioscience 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: The company's research strategy was adjusted and the study was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The type, frequency, severity and outcome of adverse events (TEAE) and serious adverse events (SAE) that occurred during the treatment period. (Phase Ib) (time frame: 2 years). The study lists 7 primary outcomes in all. 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 29 Jul 2026.