Lung Cancer, Non-Small CellPhase 1/2NCT06690671
A Single-Arm, Phase Ⅰb Study of Golidocitinib Combined With Anti-PD-1 for the Treatment of Previously Treated NSCLC
A Phase 1/2 study testing Golidocitinib in combination with anti-PD-1 in people with Lung Cancer, Non-Small Cell, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with anti-PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with anti-PD-1 in combination with or without platinum-containing chemotherapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell
- What is being tested?
- Golidocitinib in combination with anti-PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 30 Jun 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be able to provide signed and dated informed consent, including adherence to the requirements and limitations listed in the Informed Consent Form (ICF) and in this protocol;
- be ≥ 18 years of age, male or female, at the time of signing the ICF;
- ECOG score of 0 or 1;
- life expectancy ≥ 3 months;
- patients with histologically or cytologically confirmed NSCLC diagnosed as locally advanced (Stage IIIB/IIIC), metastatic or recurrent (Stage IV) according to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancers, 8th edition of the TNM staging of lung cancer, who are not suitable for radical surgery or concurrent radiotherapy;
- prior treatment with a first-line regimen of PD-1 monoclonal antibody (including, but not limited to, navulizumab, pabolizumab, treprostinil, sindilizumab, karelizumab, tirilizumab, and pegfilgrastimab) in combination with or without first-line regimen of platinum-containing chemotherapy, with a best-case outcome of CR/PR/SD that lasts at least 6 weeks;
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- intolerance to standard chemotherapy or refusal of chemotherapy;
- at least one measurable lesion (RECIST v1.1);
- adequate bone marrow reserve and organ system functional reserve, as summarized below:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L under conditions not receiving growth factor support.
- Platelets ≥ 100 × 109/L under conditions of no growth factor support or transfusion.
- Hemoglobin ≥ 9 g/dL without transfusion or receiving erythropoietin.
- Total bilirubin ≤ 1.5 × ULN; if Gilbert syndrome (unconjugated hyperbilirubinemia) is present, total bilirubin should be ≤ 3 × ULN.
- ALT and AST ≤ 2.5 × ULN; for patients with documented liver metastases, AST and ALT levels ≤ 5 × ULN.
- Blood creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method, or urinary creatinine clearance ≥ 50 mL/min measured over 24 hours.
- For patients with central nervous system metastases, the following conditions must be met for enrollment:
- Absence of neurological symptoms or stabilization of symptoms for at least 2 weeks with local therapy, no need for corticosteroids or antiepileptic drugs, and cessation of hormone therapy within 3 days prior to the first study drug administration;
- If the brain metastatic lesion has been treated locally (radiotherapy or surgery), there should be a window of ≥ 2 weeks prior to the first administration of study drug to ensure that adverse events related to local treatment have been reduced to CTCAE ≤ Grade 1.
- Women of Childbearing Potential (WOCBP) must have a negative urine and/or serum (if the urine test is not confirmably negative) pregnancy test performed within 7 days prior to the first dose of study drug; the WOCBP or the man and his WOCBP partner should agree to take a urine and/or serum (if the urine test is not confirmably negative) pregnancy test from the time of signing the ICF until the last dose of 6 months after use of study drug to use effective contraception.
Who cannot join
- histopathologically confirmed presence of a mixture of NSCLC and small cell lung cancer components;
- the known presence of an EGFR-sensitive mutation/exon 20 insertion mutation or ALK/ROS1/RET fusion or MET14 jump mutation;
- the known presence of interstitial pneumonitis/immune pneumonitis or interstitial changes
- the known presence of spinal cord compression or meningeal metastases;
- a history of any of the following:
- Currently participating in an interventional clinical study treatment and any drug still in the developmental phase requiring a washout of 5 half-lives (or discuss with study team);
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- Received palliative radiotherapy within 2 weeks prior to the first dose, for more than 30% of the bone marrow for radiotherapy or extensive radiotherapy, which needs to be completed within 4 weeks prior to the first dose;
- Currently receiving (or unable to discontinue use of) medications, herbal supplements, and foods known to be potent inducers or potent inhibitors of CYP3A at least 1 week prior to first dose;
- Presence of an adverse event due to prior therapy via CTCAE > Grade 1 (with the exception of any degree of alopecia) prior to the first dose;
- Known serious hematologic adverse event caused by a drug on prior first-line therapy that does not recover within 7 days to a Common Criteria for Terminology of Adverse Events (CTCAE) 5.0 rating of 2 or less.
- receipt of a solid organ or hematologic transplant (e.g., previous allogeneic bone marrow transplant or whole blood transfusion within 120 days of sample collection during the study period)
- subjects with severe pulmonary function decline (i.e., any FEV1 or DLCO < 60% of predicted). Prior interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone therapy or current clinically active interstitial lung disease (including interstitial changes in the lungs), immunotherapy-induced immune pneumonitis of degree 3 or greater or resulting in treatment termination;
- active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy;
- physiologic doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted for a diagnosis of immunodeficiency or if systemic glucocorticoid therapy or any other form of immunosuppressive therapy is being received within 7 days prior to the first dose of the study;
- diagnosis of another malignancy within 5 years prior to the first dose, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ that has been evaluated and clinically cured;
- vaccination with live vaccines, including live attenuated vaccines, except inactivated vaccines, within 30 days prior to the first dose (Cycle 1, Day 1);
- active tuberculosis as determined by the Investigator, such as a positive tuberculin (PPD) test (nodule diameter > 10 mm), a positive T-SPOT test, a tuberculosis lesion on chest X-ray/CT, or other positive findings based on routine clinical screening (except for those cured by standardized anti-TB treatment as assessed by the Investigator);
- subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV) human immunodeficiency virus (HIV); (1) Active HCV and HIV infection, i.e., positive test results for the respective antibodies; 2) Untreated active hepatitis B, defined as HBsAg-positive with HBV DNA ≥1000 IU/ml or HBcAb-positive with HBV DNA ≥1000 IU/ml; however, study participants who meet the following conditions may also be enrolled:
- HBsAg-positive with HBV DNA <1000 IU/ml prior to the first dose of study drug, study participants should receive anti-HBV therapy to prevent viral reactivation throughout the study treatment period;
- For HBsAg-negative, HBcAb-positive participants with HBV DNA <1000 IU/ml, study participants should be tested for HBV DNA throughout the duration of study treatment. 14.
- hypersensitivity to the medications used in the study or their components;
- have difficulty swallowing, or have an active digestive disorder, or have undergone major gastrointestinal surgery that may significantly interfere with the administration or absorption of the trial drug (e.g., ulcerative lesions, inability to swallow medications, uncontrollable nausea, vomiting, diarrhea, and malabsorption syndromes);
- who, in the opinion of the investigator, are not suitable for participation in this study.
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
241, West Huaihai Road, Shanghai, Shanghai, Shanghai 200030
Shanghai, Shanghai Municipality, 200030
Hua Zhong, MD, +86-021-22200000, eddiedong8@hotmail.com
About this study
Official title: An Open-Label, Single-Arm, Phase Ib Exploratory Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Anti-PD-1 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With First-Line Anti-PD-1 Containing Regimens
This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with anti-PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with anti-PD-1 in combination with or without platinum-containing chemotherapy regimens.
Read the detailed description
This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with PD-1 monoclonal antibody in combination with or without platinum-containing chemotherapy regimens. The purpose of this part is to obtain the safety profile of the Golidocitinib in combination with PD-1 monoclonal antibody regimen in subjects with NSCLC who have failed treatment with first-line PD-1 monoclonal antibody in combination with or without platinum-containing chemotherapeutic regimens, and the recommended dose of the combination. The study will enroll 30 patients receiving Golidocitinib administered once daily (orally) at a starting dose of 75 mg up to a maximum dose of 150 mg; PD-1 monoclonal antibody at a clinically standardized dose (e.g., 200 mg IV Q3W), until the patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint was ORR, and secondary endpoints included PFS, DCR, OS, and safety. The study is expected to commence recruitment in mainland China in about Dec 2024. It is expected that the trial will end in July 2027.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Golidocitinib in combination with anti-PD-1
- Keywords
- JAKi, anti-PD-1, resitance
- 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.
Golidocitinib in combination with anti-PD-1Drug
Golidocitinib 150/75 mg once daily (QD) with anti-PD-1 （200 mg IV Q3W），21 days in one cycle.
| Study group | Role | What they receive |
|---|---|---|
| Golidocitinib in combination with anti-PD-1 | Experimental | Golidocitinib 150/75 mg once daily (QD) with anti-PD-1 （200 mg IV Q3W），21 days in one cycle. Receives: Drug: Golidocitinib in combination with anti-PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
To assess Golidocitinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Measured: Time from first dose to last dose, or up to 24 month
Secondary outcomes (4)
Progression-free survival (PFS)
To assess progression-free survival of patients treated by Golidocitinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause
Measured: Time from first subject dose to study completion, or up to 36 month
Duration of Response (DoR)
To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death
Measured: Time from first subject dose to study completion, or up to 36 month
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause
Measured: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: From first dose until 28 days after the last dose, up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhong, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690671
- Sponsor's protocol ID
- IS24147
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 15 Nov 2024
- 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase Ib Exploratory Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Anti-PD-1 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With First-Line Anti-PD-1 Containing Regimens
- ClinicalTrials.gov ID
- NCT06690671
- Acronym / sponsor ID
- IS24147
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- JAKi, anti-PD-1, resitance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Nov 2024 (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 study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with anti-PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with anti-PD-1 in combination with or without platinum-containing chemotherapy regimens.
Detailed description
This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with PD-1 monoclonal antibody in combination with or without platinum-containing chemotherapy regimens. The purpose of this part is to obtain the safety profile of the Golidocitinib in combination with PD-1 monoclonal antibody regimen in subjects with NSCLC who have failed treatment with first-line PD-1 monoclonal antibody in combination with or without platinum-containing chemotherapeutic regimens, and the recommended dose of the combination. The study will enroll 30 patients receiving Golidocitinib administered once daily (orally) at a starting dose of 75 mg up to a maximum dose of 150 mg; PD-1 monoclonal antibody at a clinically standardized dose (e.g., 200 mg IV Q3W), until the patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint was ORR, and secondary endpoints included PFS, DCR, OS, and safety. The study is expected to commence recruitment in mainland China in about Dec 2024. It is expected that the trial will end in July 2027.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib in combination with anti-PD-1 | Experimental | Drug: Golidocitinib in combination with anti-PD-1Golidocitinib 150/75 mg once daily (QD) with anti-PD-1 （200 mg IV Q3W），21 days in one cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- be able to provide signed and dated informed consent, including adherence to the requirements and limitations listed in the Informed Consent Form (ICF) and in this protocol;
- be ≥ 18 years of age, male or female, at the time of signing the ICF;
- ECOG score of 0 or 1;
- life expectancy ≥ 3 months;
- patients with histologically or cytologically confirmed NSCLC diagnosed as locally advanced (Stage IIIB/IIIC), metastatic or recurrent (Stage IV) according to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancers, 8th edition of the TNM staging of lung cancer, who are not suitable for radical surgery or concurrent radiotherapy;
Key exclusion criteria (23 listed)
- histopathologically confirmed presence of a mixture of NSCLC and small cell lung cancer components;
- the known presence of an EGFR-sensitive mutation/exon 20 insertion mutation or ALK/ROS1/RET fusion or MET14 jump mutation;
- the known presence of interstitial pneumonitis/immune pneumonitis or interstitial changes
- the known presence of spinal cord compression or meningeal metastases;
- a history of any of the following:
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 |
|---|---|---|
| Golidocitinib in combination with anti-PD-1Golidocitinib 150/75 mg once daily (QD) with anti-PD-1 （200 mg IV Q3W），21 days in one cycle. | Drug | Golidocitinib in combination with anti-PD-1 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Time from first dose to last dose, or up to 24 month
To assess Golidocitinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
4 secondary outcomes
Progression-free survival (PFS)
Time frame: Time from first subject dose to study completion, or up to 36 month
Duration of Response (DoR)
Time frame: Time from first subject dose to study completion, or up to 36 month
Overall survival (OS)
Time frame: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Time frame: From first dose until 28 days after the last dose, up to 24 month
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 15 Nov 2024.
- 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.
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 Golidocitinib in combination with anti-PD-1 in people with Lung Cancer, Non-Small Cell, run by Shanghai Chest 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 19 inclusion and 23 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 15 Nov 2024. 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?
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 Hua Zhong, MD (+86-021-22200000, eddiedong8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Time from first dose to last dose, or up to 24 month). 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 15 Nov 2024.