NSCLCPhase 2NCT06746870
A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer
A Phase 2 study testing IMM2510, Chemotherapy (pemetrexed + cisplatin/carboplatin) and Chemotherapy (paclitaxel + cisplatin/carboplatin) in people with NSCLC and TNBC, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc..
Trial summary
This is a single-arm, multicenter, open-label Phase II clinical study evaluating the efficacy and safety of IMM2510 in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic TNBC. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- IMM2510, Chemotherapy (pemetrexed + cisplatin/carboplatin) and Chemotherapy (paclitaxel + cisplatin/carboplatin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand and voluntarily sign the ICF for this study ;
- Aged ≥ 18 years old;
- Cohort 1: NSCLC; EGFR wild-type and negative for ALK or ROS1 fusion genes. Cohort 1a: Non-squamous NSCLC (NSQ-NSCLC); Cohort 1b: Squamous NSCLC (SQ-NSCLC); Cohort 2: Breast cancer, negative for ER, PR, and HER-2. Definition of negative for ER and PR: IHC ER < 1%, IHC PR < 1%. Definition of negative for HER-2: IHC HER-2 (-) or (1+); for HER-2 (2+), FISH testing must be performed and the result must be negative;
- Cohort 1: Previous systemic treatment for advanced NSCLC has not been received. If neoadjuvant and/or adjuvant treatment was previously received, the time from the completion of neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for NSCLC; Cohort 2: Previous systemic treatment for advanced TNBC has not been received. If neoadjuvant and/or adjuvant treatment included taxane-based anti-tumor treatment, the time from the completion of taxane-based neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for TNBC;
- ECOG score of 0 or 1;
- Have measurable lesions (according to RECIST 1.1).
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- Expected survival ≥ 12 weeks;
- Provide archival tumor tissue samples or newly obtained needle biopsy or surgical resection samples of tumor lesions (previously unirradiated) for central PD-L1 and other biomarker tests. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred over slides. Newly obtained biopsy samples are preferred over archival samples. Formalin-fixed samples are preferred after the subject is diagnosed with metastatic disease. If a recent biopsy is not feasible, biopsy samples obtained prior to adjuvant/neoadjuvant chemotherapy are acceptable.
- Upon signing the ICF, females of childbearing potential and males must agree to practice effective contraception during the study and for 6 months after the last dose, and females of childbearing potential must have a negative result for pregnancy test within 3 days pre-dose;
Who cannot join
- Received approved or investigational anti-tumor treatments within 4 weeks prior to the start of study treatment
- Received nonspecific immunomodulatory treatments within 2 weeks prior to the start of study treatment;
- Previously received any antibody or inhibitor targeting PD-1/PD-L1 or VEGF;
- Laboratory abnormalities
- History of pulmonary fibrosis or current presence of severe pulmonary functional impairment
- Uncontrolled chronic disease
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- Unresolved toxicity
- Uncontrolled brain metastases
- Active infection
- Bleeding Risk
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Qiying Lu, MD contact
About this study
This is a single-arm, multicenter, open-label Phase II clinical study evaluating the efficacy and safety of IMM2510 in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic TNBC.
The target population includes: Cohort 1: Patients with histologically or cytologically confirmed stage IV metastatic or recurrent NSCLC who are EGFR wild-type and negative for ALK or ROS1 fusion genes, and who have not received prior systemic treatment for NSCLC; Cohort 2: Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic TNBC who are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2), and who have not received prior systemic treatment for TNBC; This study is divided into two phases. Phase I is the safety run-in period, which will preliminarily explore the safety and PK profile of IMM2510 in combination with chemotherapy in patients with NSCLC or TNBC who have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment, to determine the dose for the combination treatment. Phase II is the expanded enrollment period, which will enroll NSCLC patients (Cohort 1; where Cohort 1a is for NSQ-NSCLC and Cohort 1b is for SQ-NSCLC), or TNBC patients (Cohort 2), according to the dose for the combination treatment determined in Phase I, to further explore the preliminary clinical efficacy, safety, and PK profile of IMM2510 in combination with chemotherapy as first-line treatment in patients with NSCLC or TNBC.
- Being tested
- IMM2510, Chemotherapy (pemetrexed + cisplatin/carboplatin), Chemotherapy (paclitaxel + cisplatin/carboplatin), Chemotherapy(Nab-paclitaxel)
- Keywords
- NSCLC, TNBC, IMM2510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM2510Drug
Cohort1:
Phase I #: 10 mg/kg or 20 mg/kg, Q3W, intravenous infusion Phase II \&: 20 mg/kg, Q3W, intravenous infusion
Cohort2:
Phase I #: 10 mg/kg or 20 mg/kg, Q2W, intravenous infusion Phase II \&: 20 mg/kg, Q2W, intravenous infusion
Chemotherapy (pemetrexed + cisplatin/carboplatin)Drug
Non-squamous non-small cell lung cancer (NQ-NSCLC): Pemetrexed 500 mg/m2 in combination with carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles, followed by maintenance treatment with pemetrexed
Chemotherapy (paclitaxel + cisplatin/carboplatin)Drug
Squamous non-small cell lung cancer (SQ-NSCLC): Paclitaxel 175 mg/m2 + carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles.
Chemotherapy(Nab-paclitaxel)Drug
Nab-paclitaxel, 100 mg/m2, 4 weeks as a cycle, administered on D1, 8, and 15 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a | Experimental | NSQ-NSCLC Receives: Drug: IMM2510; Drug: Chemotherapy (pemetrexed + cisplatin/carboplatin) |
| Cohort 1b | Experimental | SQ-NSCLC Receives: Drug: IMM2510; Drug: Chemotherapy (paclitaxel + cisplatin/carboplatin) |
| Cohort 2 | Experimental | TNBC Receives: Drug: IMM2510; Drug: Chemotherapy(Nab-paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the preliminary clinical efficacy of IMM2510 for Injection in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent non-small cell lung cancer (NSCLC)
Objective response rate for NSQ-NSCLC (ORR, assessed by the investigator) Objective response rate for SQ-NSCLC (ORR, assessed by the investigator)
Measured: 96 weeks
To evaluate the preliminary clinical efficacy of IMM2510 for Injection in combination with nab-paclitaxel as first-line treatment in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
ORR (intention-to-treat (ITT), assessed by the investigator)
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiying Lu, MD, Study director, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746870
- Sponsor's protocol ID
- IMM2510-003
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06746870
- Acronym / sponsor ID
- IMM2510-003
- Keywords
- NSCLC, TNBC, IMM2510
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Dec 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 single-arm, multicenter, open-label Phase II clinical study evaluating the efficacy and safety of IMM2510 in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic TNBC.
The target population includes: Cohort 1: Patients with histologically or cytologically confirmed stage IV metastatic or recurrent NSCLC who are EGFR wild-type and negative for ALK or ROS1 fusion genes, and who have not received prior systemic treatment for NSCLC; Cohort 2: Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic TNBC who are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2), and who have not received prior systemic treatment for TNBC; This study is divided into two phases. Phase I is the safety run-in period, which will preliminarily explore the safety and PK profile of IMM2510 in combination with chemotherapy in patients with NSCLC or TNBC who have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment, to determine the dose for the combination treatment. Phase II is the expanded enrollment period, which will enroll NSCLC patients (Cohort 1; where Cohort 1a is for NSQ-NSCLC and Cohort 1b is for SQ-NSCLC), or TNBC patients (Cohort 2), according to the dose for the combination treatment determined in Phase I, to further explore the preliminary clinical efficacy, safety, and PK profile of IMM2510 in combination with chemotherapy as first-line treatment in patients with NSCLC or TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a | Experimental | Drug: IMM2510, Drug: Chemotherapy (pemetrexed + cisplatin/carboplatin)NSQ-NSCLC |
| Cohort 1b | Experimental | Drug: IMM2510, Drug: Chemotherapy (paclitaxel + cisplatin/carboplatin)SQ-NSCLC |
| Cohort 2 | Experimental | Drug: IMM2510, Drug: Chemotherapy(Nab-paclitaxel)TNBC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand and voluntarily sign the ICF for this study ;
- Aged ≥ 18 years old;
- Cohort 1: NSCLC; EGFR wild-type and negative for ALK or ROS1 fusion genes. Cohort 1a: Non-squamous NSCLC (NSQ-NSCLC); Cohort 1b: Squamous NSCLC (SQ-NSCLC); Cohort 2: Breast cancer, negative for ER, PR, and HER-2. Definition of negative for ER and PR: IHC ER < 1%, IHC PR < 1%. Definition of negative for HER-2: IHC HER-2 (-) or (1+); for HER-2 (2+), FISH testing must be performed and the result must be negative;
- Cohort 1: Previous systemic treatment for advanced NSCLC has not been received. If neoadjuvant and/or adjuvant treatment was previously received, the time from the completion of neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for NSCLC; Cohort 2: Previous systemic treatment for advanced TNBC has not been received. If neoadjuvant and/or adjuvant treatment included taxane-based anti-tumor treatment, the time from the completion of taxane-based neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for TNBC;
- ECOG score of 0 or 1;
Key exclusion criteria (10 listed)
- Received approved or investigational anti-tumor treatments within 4 weeks prior to the start of study treatment
- Received nonspecific immunomodulatory treatments within 2 weeks prior to the start of study treatment;
- Previously received any antibody or inhibitor targeting PD-1/PD-L1 or VEGF;
- Laboratory abnormalities
- History of pulmonary fibrosis or current presence of severe pulmonary functional impairment
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 |
|---|---|---|
| IMM2510Cohort1: Phase I #: 10 mg/kg or 20 mg/kg, Q3W, intravenous infusion Phase II \&: 20 mg/kg, Q3W, intravenous infusion Cohort2: Phase I #: 10 mg/kg or 20 mg/kg, Q2W, intravenous infusion Phase II \&: 20 mg/kg, Q2W, intravenous infusion | Drug | Cohort 1a, Cohort 1b, Cohort 2 |
| Chemotherapy (pemetrexed + cisplatin/carboplatin)Non-squamous non-small cell lung cancer (NQ-NSCLC): Pemetrexed 500 mg/m2 in combination with carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles, followed by maintenance treatment with pemetrexed | Drug | Cohort 1a |
| Chemotherapy (paclitaxel + cisplatin/carboplatin)Squamous non-small cell lung cancer (SQ-NSCLC): Paclitaxel 175 mg/m2 + carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles. | Drug | Cohort 1b |
| Chemotherapy(Nab-paclitaxel)Nab-paclitaxel, 100 mg/m2, 4 weeks as a cycle, administered on D1, 8, and 15 of each cycle. | Drug | Cohort 2 |
Primary outcome
To evaluate the preliminary clinical efficacy of IMM2510 for Injection in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent non-small cell lung cancer (NSCLC)
Time frame: 96 weeks
Objective response rate for NSQ-NSCLC (ORR, assessed by the investigator) Objective response rate for SQ-NSCLC (ORR, assessed by the investigator)
To evaluate the preliminary clinical efficacy of IMM2510 for Injection in combination with nab-paclitaxel as first-line treatment in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Time frame: 96 weeks
ORR (intention-to-treat (ITT), assessed by the investigator)
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 24 Dec 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.
Qiying Lu, MD contact
Qiying Lu, MD study director
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMM2510, Chemotherapy (pemetrexed + cisplatin/carboplatin) and Chemotherapy (paclitaxel + cisplatin/carboplatin) in people with NSCLC and TNBC, run by ImmuneOnco Biopharmaceuticals (Shanghai) 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 10 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 24 Dec 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 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 Qiying Lu, MD (qiying.lu@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the preliminary clinical efficacy of IMM2510 for Injection in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent non-small cell lung cancer (NSCLC) (time frame: 96 weeks). 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 24 Dec 2024.