Lung CancerPhase 2NCT06421298
A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
A Phase 2 study testing Tafolecimab, Sintilimab and Nab paclitaxel in people with Lung Cancer, run by Jinghui Wang at 1 site in China.
Trial summary
The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Tafolecimab, Sintilimab and Nab paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2024to 30 May 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
- Sign a written informed consent before implementing any procedures related to the trial;
- Age ≥18 years old and ≤75 years old;
- Life expectancy ≥3 months;
- Subjects with histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (Stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint American Committee on Cancer Classification 8th Edition TNM Staging of Lung Cancer) relapse or disease progression following multimodal therapy (radiotherapy, surgical resection, or radical chemoradiotherapy for locally advanced disease);
- Patients must have previously used PD-1 or PD-Ll inhibitors and have disease progression; 1) Participants receiving maintenance therapy (meaning maintenance therapy after an immune checkpoint inhibitor regimen) and who have progressed are eligible for inclusion.
- 2) Participants treated with adjuvant, neoadjuvant, or radical chemoradiotherapy containing PD-1 or PD-Ll inhibitors for locally advanced disease and who experienced tumor recurrence or metastasis within 6 months after completion of treatment were eligible for inclusion.
Show all 16Show fewer
- 6. No EGFR, ALK and other mutations; 7. There was at least one radiographically measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1 edition). Lesions located in the previous radiation field can be considered measurable lesions if progression is demonstrated; 8. Patients with stable brain metastases or whose brain metastases can be controlled were allowed to enroll; 9. ECOG score was 0-1; 10. With sufficient organ function, subjects must meet the following laboratory indicators:
- Absolute neutrophil count (ANC) ≥1.5x10^9/L without using granulocyte colony-stimulating factor in the past 14 days;
- Without blood transfusion in the past 14 days, platelets ≥100×10^9/L;
- Hemoglobin >9g/dL without blood transfusion or erythropoietin use in the past 14 days;
- Total bilirubin ≤1.5×upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (subjects with liver metastases are allowed ALT or AST ≤5×ULN);
- Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using Cockcroft-Gault formula) ≥60 ml/min;
- Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
- Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range;
- Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities without clinical significance are also allowed to be included); 11. Female subjects of childbearing potential should undergo a urine or serum pregnancy test with a negative result within 3 days before receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal, or had undergone surgical sterilization or hysterectomy; 12. If there is a risk of pregnancy, all subjects (regardless of male or female) need to use low annual failure rate during the entire treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug). Contraceptive measures at 1%; 13. Subjects determined by the researcher to meet the admission criteria;
Who cannot join
- The pathology is small cell lung cancer (SCLC), including lung cancer that is a mixture of SCLC and NSCLC;
- Have received the following treatments:
- 1) Received systemic anti-tumor treatment within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal treatment with anti-tumor indications), etc.; 2) Have received any investigational drug treatment within 4 weeks before treatment; 3) Received large doses of immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day of prednisone or its equivalent) within 4 weeks before treatment; 4) Have received live attenuated vaccines within 4 weeks before treatment (or plan to receive live attenuated vaccines during the study); 5) Have undergone major surgery (such as open cavity, thoracotomy or Kaifu surgery) within 4 weeks before treatment, or have unhealed surgical wounds, ulcers or fractures.
- 3. There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or who stop drainage for 3 days without significant increase in effusion can be enrolled);
- 4. Subjects who have received chest radiation therapy greater than 30Gy within 6 months before treatment or palliative radiation therapy with a dose of 30Gy or less within 7 days before treatment (palliative treatment for bone lesions or intracranial lesions is allowed) Radiation Therapy);
- 5. Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
Show all 17Show fewer
- 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- 7. Those who are known to be allergic to the active ingredients or excipients of tolesimab, the study drug;
- 8. Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);
- 9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- 10. Untreated active hepatitis B (defined as HBsAg positivity and a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);
- Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
- If the HBV viral load is <1000 copies/ml (200 IU/ml) before the first dose, the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation.
- Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to be closely monitored for viral reactivation
- 11. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
- 12. Get live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccine is not allowed.
- 13. Pregnant or lactating women;
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, 1 recruiting
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality
Jinghui Wang, 13683128239, jinghuiwang2006@163.com
About this study
The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need.
This study is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
Read the detailed description
This is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
30 patients will be enrolled. These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
- Conditions
- Lung Cancer
- Being tested
- Tafolecimab, Sintilimab, Nab paclitaxel, Docetaxel, Gemcitabine
- Keywords
- Immune rechallenge
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafolecimabDrug
450mg Q4W ≤6cycle
SintilimabDrug
200mg Q3W ≤2years
Nab paclitaxelDrug
130mg/m² Q3W 4-6cycles
DocetaxelDrug
75mg/m² Q3W 4-6cycles
GemcitabineDrug
1250mg/m² Q3W 4-6cycles
| Study group | Role | What they receive |
|---|---|---|
| Tafolecimab and Sintilimab Combined With Chemotherapy | Experimental | tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine Receives: Drug: Tafolecimab; Drug: Sintilimab; Drug: Nab paclitaxel; Drug: Docetaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measured: up to 24 months
Secondary outcomes (5)
OS
OS is defined as the time until death due to any cause. OS is defined as the time until death due to any cause.
OS is defined as the time until death due to any cause.
Measured: up to 24 months
DCR
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: up to 24 months
DOR
defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier Defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier
Measured: up to 24 months
ORR
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measured: up to 24 months
AE
Evaluation of adverse event rate according to CTCAE(Common terminology criteria for adverse events) v5.0
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start17 May 2024 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinghui Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinghui Wang, Beijing Chest Hospital, Capital Medical University
- Investigators
- Beijing C Beijing Chest Hospital, Principal investigator, Employment relationship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421298
- Sponsor's protocol ID
- Immune rechallenge
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
- ClinicalTrials.gov ID
- NCT06421298
- Acronym / sponsor ID
- Immune rechallenge
- Conditions
- Lung Cancer
- Keywords
- Immune rechallenge
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jinghui WangUniversity, hospital or other
- Study start
- 17 May 2024 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 20 May 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.
The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need.
This study is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
Detailed description
This is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
30 patients will be enrolled. These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| Tafolecimab and Sintilimab Combined With Chemotherapy | Experimental | Drug: Tafolecimab, Drug: Sintilimab, Drug: Nab paclitaxel, Drug: Docetaxel, Drug: Gemcitabinetafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Sign a written informed consent before implementing any procedures related to the trial;
- Age ≥18 years old and ≤75 years old;
- Life expectancy ≥3 months;
- Subjects with histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (Stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint American Committee on Cancer Classification 8th Edition TNM Staging of Lung Cancer) relapse or disease progression following multimodal therapy (radiotherapy, surgical resection, or radical chemoradiotherapy for locally advanced disease);
- Patients must have previously used PD-1 or PD-Ll inhibitors and have disease progression; 1) Participants receiving maintenance therapy (meaning maintenance therapy after an immune checkpoint inhibitor regimen) and who have progressed are eligible for inclusion.
Key exclusion criteria (17 listed)
- The pathology is small cell lung cancer (SCLC), including lung cancer that is a mixture of SCLC and NSCLC;
- Have received the following treatments:
- 1) Received systemic anti-tumor treatment within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal treatment with anti-tumor indications), etc.; 2) Have received any investigational drug treatment within 4 weeks before treatment; 3) Received large doses of immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day of prednisone or its equivalent) within 4 weeks before treatment; 4) Have received live attenuated vaccines within 4 weeks before treatment (or plan to receive live attenuated vaccines during the study); 5) Have undergone major surgery (such as open cavity, thoracotomy or Kaifu surgery) within 4 weeks before treatment, or have unhealed surgical wounds, ulcers or fractures.
- 3. There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or who stop drainage for 3 days without significant increase in effusion can be enrolled);
- 4. Subjects who have received chest radiation therapy greater than 30Gy within 6 months before treatment or palliative radiation therapy with a dose of 30Gy or less within 7 days before treatment (palliative treatment for bone lesions or intracranial lesions is allowed) Radiation Therapy);
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 |
|---|---|---|
| Tafolecimab450mg Q4W ≤6cycle | Drug | Tafolecimab and Sintilimab Combined With Chemotherapy |
| Sintilimab200mg Q3W ≤2years | Drug | Tafolecimab and Sintilimab Combined With Chemotherapy |
| Nab paclitaxel130mg/m² Q3W 4-6cycles | Drug | Tafolecimab and Sintilimab Combined With Chemotherapy |
| Docetaxel75mg/m² Q3W 4-6cycles | Drug | Tafolecimab and Sintilimab Combined With Chemotherapy |
| Gemcitabine1250mg/m² Q3W 4-6cycles | Drug | Tafolecimab and Sintilimab Combined With Chemotherapy |
Primary outcome
PFS
Time frame: up to 24 months
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
5 secondary outcomes
OS
Time frame: up to 24 months
DCR
Time frame: up to 24 months
DOR
Time frame: up to 24 months
ORR
Time frame: up to 24 months
AE
Time frame: up to 24 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 20 May 2024.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Beijing C Beijing Chest Hospital principal investigator
Employment relationship
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 Tafolecimab, Sintilimab and Nab paclitaxel in people with Lung Cancer, run by Jinghui Wang 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 16 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 20 May 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 Jinghui Wang (13683128239, jinghuiwang2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 24 months). 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 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.