Squamous Cell Non-small Cell Lung CancerPhase 2/3NCT06319313
Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer
A Phase 2/3 study testing JMT101, docetaxel and HB1801 in people with Squamous Cell Non-small Cell Lung Cancer, run by Shanghai JMT-Bio Inc..
Trial summary
This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Non-small Cell Lung Cancer
- What is being tested?
- JMT101, docetaxel and HB1801
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Dec 2027
- Phase
- Phase 2/3
- 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
- Age ranged from 18 to 75 years old (inclusive), regardless of gender;
- Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes
- Tumor tissue available for central laboratory testing;
- Disease progression after prior anti PD-1/PD-L1 and platinum containing chemotherapy
- Measurable disease according to RECIST1.1;
- Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
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- Life expectancy ≥3 months
- Adequate main organs and bone marrow function.
- Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.
Who cannot join
- Previously used anti EGFR, or docetaxel;
- Central nervous system metastasis or meningeal metastasis;
- Patients with high risk of bleeding due to tumor invasion of important arteries;
- Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
- The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia or fatigue, which is judged to be of no safety risk by researchers;
- Diagnosed as a second primary malignant tumor (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ, etc.) within 5 years prior to the first administration of the study drug;
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- Have received anti-tumor treatments such as systemic chemotherapy, biological therapy, immunotherapy, radical radiotherapy chemotherapy, etc. within 28 days before the first dose of the study drug;
- Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
- Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;
- Have received palliative radiotherapy, small molecule targeted therapy, immunomodulatory drugs, NMPA approved modern traditional Chinese medicine preparations and other anti-tumor treatments, within 14 days before the first dose of study drug;
- Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors within 1 week, or those who cannot suspend the use of the above drugs during the study;
- Have a history of serious cardiovascular disease;
- Have a history of serious lung disease;
- History of autoimmune diseases;
- History of immunodeficiency
- A history of gastrointestinal perforation and/or fistula within 6 months, or gastrointestinal obstruction and active inflammatory bowel disease within 28 days prior to the first study drug administration
- Have infectious diseases requiring systemic anti-infective treatment;
- Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
- Known hypersensitivity or intolerance to any component of EGFR monoclonal antibody, human serum albumin, docetaxel, and its excipients; Individuals known to be allergic and/or contraindicated to glucocorticoids
- Women during lactation or pregnancy;
- Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration;
- Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Controlled, Open-label Phase II/III Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel / HB1801 in Patients With sqNSCLC
This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.
- Conditions
- Squamous Cell Non-small Cell Lung Cancer
- Being tested
- JMT101, docetaxel, HB1801
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT101Drug
JMT101, 6 mg/kg, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). or 9 mg/kg, IV infusion once every 3 weeks.
docetaxelDrug
50 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 75 mg/m2, IV infusion once every 3 weeks.
HB1801Drug
75 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2, IV infusion once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JMT101+ docetaxel | Experimental | Not described Receives: Drug: JMT101; Drug: docetaxel |
| JMT101+HB1801 | Experimental | Not described Receives: Drug: JMT101; Drug: HB1801 |
| HB1801 | Experimental | Not described Receives: Drug: HB1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Measured: Up to approximately 2 years
Overall Survival (OS)
Measured: Up to approximately 3 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: Up to approximately 3 years
Secondary outcomes (5)
Progression-free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
Measured: Up to approximately 2 years
Duration of response（DOR）
Measured: Up to approximately 2 years
JMT101 Concentrations in Plasma
Measured: Up to approximately 2 years
Total and Free Docetaxel Concentrations in Plasma
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319313
- Sponsor's protocol ID
- JMT101-013
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Phase II/III Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel / HB1801 in Patients With sqNSCLC
- ClinicalTrials.gov ID
- NCT06319313
- Acronym / sponsor ID
- JMT101-013
- Conditions
- Squamous Cell Non-small Cell Lung Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Mar 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 II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JMT101+ docetaxel | Experimental | Drug: JMT101, Drug: docetaxel |
| JMT101+HB1801 | Experimental | Drug: JMT101, Drug: HB1801 |
| HB1801 | Experimental | Drug: HB1801 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ranged from 18 to 75 years old (inclusive), regardless of gender;
- Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes
- Tumor tissue available for central laboratory testing;
- Disease progression after prior anti PD-1/PD-L1 and platinum containing chemotherapy
- Measurable disease according to RECIST1.1;
Key exclusion criteria (22 listed)
- Previously used anti EGFR, or docetaxel;
- Central nervous system metastasis or meningeal metastasis;
- Patients with high risk of bleeding due to tumor invasion of important arteries;
- Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
- The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia or fatigue, which is judged to be of no safety risk by researchers;
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 |
|---|---|---|
| JMT101JMT101, 6 mg/kg, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). or 9 mg/kg, IV infusion once every 3 weeks. | Drug | JMT101+ docetaxel, JMT101+HB1801 |
| docetaxel50 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 75 mg/m2, IV infusion once every 3 weeks. | Drug | JMT101+ docetaxel |
| HB180175 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2, IV infusion once every 3 weeks. | Drug | HB1801, JMT101+HB1801 |
Primary outcome
Overall response rate (ORR)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: Up to approximately 3 years
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Duration of response（DOR）
Time frame: Up to approximately 2 years
JMT101 Concentrations in Plasma
Time frame: Up to approximately 2 years
Total and Free Docetaxel Concentrations in Plasma
Time frame: Up to approximately 2 years
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 20 Mar 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.
Li Zhang, M.D. principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JMT101, docetaxel and HB1801 in people with Squamous Cell Non-small Cell Lung Cancer, run by Shanghai JMT-Bio Inc..
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 9 inclusion and 22 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Up to approximately 2 years). The study lists 3 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 20 Mar 2024.