Non-Small-Cell Lung CancerPhase 2JACKPOT33NCT06198907
Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)
A Phase 2 study testing Golidocitinib, Sintilimab and platinum doublet chemotherapy in people with Non-Small-Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC) 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?
- Golidocitinib, Sintilimab and platinum doublet chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Dec 2027
- 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
- Be able to provide a signed and dated, written informed consent.
- Adults aged ≥18 to 75 years.
- ECOG performance status 0-1.
- Predicted life expectancy ≥ 12 weeks
- Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th
- Without EGFR or ALK mutations.
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- Adequate bone marrow reserve and organ system functions.
- Patients with stable and symptomatic brain metastasis (BM) can be enrolled.
- Part A Dose escalation:
- Patients must have relapsed after or been refractory/intolerant to ≥ 1 prior systemic therapy(ies) for NSCLC
- Part B dose expansion:
- At least one measurable lesion according to RECIST 1.1.
- Previously systemic untreated for advanced disease.
- PD-L1 TPS ≥ 50% (cohort 1), PD-L1 TPS 1-49% (cohort 2)
Who cannot join
- Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Prior malignancy within 5 years
- History of organ transplantation or hematopoietic stem cell transplantation
- Sever lung function decline or interstitial lung disease that has required oral or IV steroids
- Active autoimmune disease requiring systemic therapy within 2 years
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- Immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment.
- Active infections
- Significant cardiac disorder
- Other serious or uncontrolled systemic diseases assessed by the investigator.
- Part A Dose escalation:
- 1. Prior systemic therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137) within 4 weeks
- Part B Dose Expansion:
- Any prior systemic anti-tumor therapy
- Prior systemic immunotherapy, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137)
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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jie Wang, MD, PhD, 010-87788219, zlhuxi@163.com
About this study
Official title: A Phase 2, Open-label, Single Arm Study to Investigate the Safety and Efficiency of Golidocitinib in Combination With Sintilimab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With PD-L1TPS ≥ 1%)
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Golidocitinib, Sintilimab, platinum doublet chemotherapy
- 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.
GolidocitinibDrug
Daily dosing of golidocitinib
SintilimabDrug
Sintilimab, 200mg, intravenous, every 3 weeks.
platinum doublet chemotherapyDrug
Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose escalation | Experimental | Dose escalation part Golidocitinib in combination with sintilimab Receives: Drug: Golidocitinib; Drug: Sintilimab |
| Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%) | Experimental | Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab Receives: Drug: Golidocitinib; Drug: Sintilimab |
| Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%) | Experimental | Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy Receives: Drug: Golidocitinib; Drug: Sintilimab; Drug: platinum doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) (cohort1)
Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1
Measured: through study completion, an average of 1 year
Progression-free survival (PFS) (cohort2)
Time from first administration of study drug to first documented disease progression or death per investigator assessment according to RECIST 1.1
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Overall survival (OS)
time from first administration of study drug to death
Measured: through study completion, up to 36 months
Incidence of Adverse Events
Frequency an severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: through study completion, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dizal Pharmaceuticals
- Responsible party
- Principal investigator, Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jie Wang, MD,PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198907
- Sponsor's protocol ID
- DZ2023J0002
- Acronym
- JACKPOT33
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 10 Jan 2024
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Single Arm Study to Investigate the Safety and Efficiency of Golidocitinib in Combination With Sintilimab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With PD-L1TPS ≥ 1%)
- ClinicalTrials.gov ID
- NCT06198907
- Acronym / sponsor ID
- JACKPOT33 / DZ2023J0002
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Dizal Pharmaceuticals
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jan 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 is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A Dose escalation | Experimental | Drug: Golidocitinib, Drug: SintilimabDose escalation part Golidocitinib in combination with sintilimab |
| Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%) | Experimental | Drug: Golidocitinib, Drug: SintilimabDose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab |
| Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%) | Experimental | Drug: Golidocitinib, Drug: Sintilimab, Drug: platinum doublet chemotherapyDose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be able to provide a signed and dated, written informed consent.
- Adults aged ≥18 to 75 years.
- ECOG performance status 0-1.
- Predicted life expectancy ≥ 12 weeks
- Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th
Key exclusion criteria (15 listed)
- Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Prior malignancy within 5 years
- History of organ transplantation or hematopoietic stem cell transplantation
- Sever lung function decline or interstitial lung disease that has required oral or IV steroids
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 |
|---|---|---|
| GolidocitinibDaily dosing of golidocitinib | Drug | Part A Dose escalation, Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%), Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%) |
| SintilimabSintilimab, 200mg, intravenous, every 3 weeks. | Drug | Part A Dose escalation, Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%), Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%) |
| platinum doublet chemotherapyPemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles | Drug | Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%) |
Primary outcome
Overall response rate (ORR) (cohort1)
Time frame: through study completion, an average of 1 year
Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1
Progression-free survival (PFS) (cohort2)
Time frame: through study completion, an average of 1 year
Time from first administration of study drug to first documented disease progression or death per investigator assessment according to RECIST 1.1
2 secondary outcomes
Overall survival (OS)
Time frame: through study completion, up to 36 months
Incidence of Adverse Events
Time frame: through study completion, up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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.
Jie Wang, MD,PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Golidocitinib, Sintilimab and platinum doublet chemotherapy in people with Non-Small-Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 14 inclusion and 15 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 10 Jan 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 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 Jie Wang, MD,PhD (010-87788219, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (cohort1) (time frame: through study completion, an average of 1 year). The study lists 2 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 10 Jan 2024.