Primary Pulmonary Lymphoepithelioma-like CarcinomaPhase 2NCT04312204
Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma
A Phase 2 study testing Sintilimab combined with Gemcitabine and Carboplatin in people with Primary Pulmonary Lymphoepithelioma-like Carcinoma and Lung Cancer, run by Zhou Chengzhi at 1 site in China.
Trial summary
The trial was designed to explore the safety and efficacy of sintilimab combined with gemcitabine and carboplatin in the treatment of advanced LELC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Pulmonary Lymphoepithelioma-like Carcinoma, Lung Cancer
- What is being tested?
- Sintilimab combined with Gemcitabine and Carboplatin
- 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
- Mar 2020to Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 1. age 18-75, male or female;
- 2. patients with advanced (inoperable stage iiiib -IV) primary pulmonary lymphoepithelioid carcinoma diagnosed pathologically, with at least one measurable lesion meeting RECIST v1.1 criteria;
- 3. patients have not received systemic therapy before (patients who have received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or radical chemoradiotherapy for advanced disease can enter if the disease progression occurs 6 months after the end of the last treatment);
- 4. ECOG PS: 0-1; expected survival ≥12 weeks;
- 5. vital organ functions meet the following requirements (excluding the use of any blood components or cytokines during screening) :The absolute count of neutrophils ≥1.5×109/L;Platelet ≥90×109/L;Hemoglobin ≥9g/dL;Serum albumin ≥3g/dL;Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group);Bilirubin ≤ULN;ALT and AST≤1.5 ULN;AKP 2.5 x ULN or less;Serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min;
- 6. women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment and have had negative results and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug. For men, consent must be given to appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the trial drug;
- 7. subjects voluntarily participate in this study and sign informed consent, with good compliance and follow up.
Who cannot join
- 1. those who have used other drugs to study drugs in clinical trials within 4 weeks before the first drug use;
- 2. the presence of any active autoimmune diseases or a history of autoimmune diseases (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or decreased thyroid function; Subjects with vitiligo or with complete remission of asthma in childhood were included without any intervention in adulthood. Subjects with asthma requiring medical intervention with bronchodilators were not included.
- 3. subjects who are using immunosuppressive agents, or systemic, or absorbable local hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones) and continue to use within 2 weeks prior to enrollment;
- 4. severe allergic reaction to monoclonal antibody;
- 5. subjects with clinically symptomatic CNS metastases (e.g. cerebral edema, need for hormone intervention, or progression of brain metastases). Patients who have received previous treatment for brain or meningeal metastasis, such as clinical stability (MRI) has been maintained for at least 2 months, and who have stopped systemic sex hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) for more than 2 weeks can be included.
- 6. subjects have heart clinical symptoms or diseases that are not well controlled, such as: a. NYHA grade 2 or above heart failure; B. unstable angina pectoris; C. Had myocardial infarction within 1 year; D. Supraventricular or ventricular arrhythmias of clinical significance require treatment or intervention;
Show all 12Show fewer
- 7. subjects who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy, and who have received less than 4 weeks before the study (or 5 drug half-lives, with the selected time) after the completion of the treatment (the last medication); Adverse events caused by previous treatment (except hair loss) did not recover to ≤ 1 degree CTCAE;
- 8. subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (hepatitis b reference: HBsAg positive, HBV DNA≥2000 IU/ml or copy number ≥104/ml; Hepatitis c reference: positive HCV antibody;
- 9. subjects with active infection or unexplained fever >38.5 degrees during screening or before first administration;
- 10. subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (hepatitis b reference: HBsAg positive, HBV DNA≥2000 IU/ml or copy number ≥104/ml; Hepatitis c reference: positive HCV antibody;
- 11. other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix of the cervix) that the subjects had had or had at the same time;
- 12. according to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory examination abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhou Chengzhi
Guangzhou, Guangdong, 510120
Chengzhi Zhou, Professor, 13560351186, doctorzcz@163.com
About this study
Official title: Exploratory Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma（LELC）
The trial was designed to explore the safety and efficacy of sintilimab combined with gemcitabine and carboplatin in the treatment of advanced LELC.
- Being tested
- Sintilimab combined with Gemcitabine and Carboplatin
- Keywords
- sintilimab, gemcitabine, Carboplatin, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab combined with Gemcitabine and CarboplatinDrug
The patients will received Gemcitabine1000mg/m2(d1,d8)(iv)+carboplatin AUC 5 (d1)(iv),4 cycles, Sintilimab 200 mg (3mg/kg when the weight <40kg ) (d1) (iv) in one cycle every 3 weeks, until PD or death.
Radiological examinations (according to the RECIST 1.1 criteria) at baseline will be repeated for tumor response evaluation following every two cycles of chemotherapy. Patients will be followed up to 30 days after the last dose of study chemotherapy, and then every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab+Gemcitabine+Carboplatin | Experimental | Not described Receives: Drug: Sintilimab combined with Gemcitabine and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria
Measured: Approximately 18 months
safety(Adverse Events)
Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)
Measured: From the day the patient signs informed consent form until 30 days after last dose of sintilimab
quality of life（the patient report outcome）
Each patient answers to specific questions in questionnaire The time frame of most questions is "How would you rate your quality fo life during the last month"
Measured: From the day the patient received treatment until 30 days after last dose of sintilimab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Pulmonary Lymphoepithelioma-like CarcinomaStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312204
- Sponsor's protocol ID
- CROC2001
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin X, Deng H, Fang N, Chen L, Chen R, Xie X, Xie Z, Zhang J, Liu M, Liu L, Sun N, Wang F, Yang Y, Lv X, Zhang Z, Cai S, Hou T, Li S, He J, Zhou C. Sintilimab plus chemotherapy for first-line treatment of advanced pulmonary lymphoepithelioma-like carcinoma: Phase 2 trial. Cell Rep Med. 2025 Oct 21;6(10):102398. doi: 10.1016/j.xcrm.2025.102398. Epub 2025 Oct 6.
PubMed 41056950
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma（LELC）
- ClinicalTrials.gov ID
- NCT04312204
- Acronym / sponsor ID
- CROC2001
- Keywords
- sintilimab, gemcitabine, Carboplatin, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 18 Mar 2020 (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 trial was designed to explore the safety and efficacy of sintilimab combined with gemcitabine and carboplatin in the treatment of advanced LELC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab+Gemcitabine+Carboplatin | Experimental | Drug: Sintilimab combined with Gemcitabine and Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. age 18-75, male or female;
- 2. patients with advanced (inoperable stage iiiib -IV) primary pulmonary lymphoepithelioid carcinoma diagnosed pathologically, with at least one measurable lesion meeting RECIST v1.1 criteria;
- 3. patients have not received systemic therapy before (patients who have received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or radical chemoradiotherapy for advanced disease can enter if the disease progression occurs 6 months after the end of the last treatment);
- 4. ECOG PS: 0-1; expected survival ≥12 weeks;
- 5. vital organ functions meet the following requirements (excluding the use of any blood components or cytokines during screening) :The absolute count of neutrophils ≥1.5×109/L;Platelet ≥90×109/L;Hemoglobin ≥9g/dL;Serum albumin ≥3g/dL;Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group);Bilirubin ≤ULN;ALT and AST≤1.5 ULN;AKP 2.5 x ULN or less;Serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min;
Key exclusion criteria (12 listed)
- 1. those who have used other drugs to study drugs in clinical trials within 4 weeks before the first drug use;
- 2. the presence of any active autoimmune diseases or a history of autoimmune diseases (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or decreased thyroid function; Subjects with vitiligo or with complete remission of asthma in childhood were included without any intervention in adulthood. Subjects with asthma requiring medical intervention with bronchodilators were not included.
- 3. subjects who are using immunosuppressive agents, or systemic, or absorbable local hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones) and continue to use within 2 weeks prior to enrollment;
- 4. severe allergic reaction to monoclonal antibody;
- 5. subjects with clinically symptomatic CNS metastases (e.g. cerebral edema, need for hormone intervention, or progression of brain metastases). Patients who have received previous treatment for brain or meningeal metastasis, such as clinical stability (MRI) has been maintained for at least 2 months, and who have stopped systemic sex hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) for more than 2 weeks can be included.
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 |
|---|---|---|
| Sintilimab combined with Gemcitabine and CarboplatinThe patients will received Gemcitabine1000mg/m2(d1,d8)(iv)+carboplatin AUC 5 (d1)(iv),4 cycles, Sintilimab 200 mg (3mg/kg when the weight <40kg ) (d1) (iv) in one cycle every 3 weeks, until PD or death. Radiological examinations (according to the RECIST 1.1 criteria) at baseline will be repeated for tumor response evaluation following every two cycles of chemotherapy. Patients will be followed up to 30 days after the last dose of study chemotherapy, and then every 3 months. | Drug | Sintilimab+Gemcitabine+Carboplatin |
Primary outcome
objective response rate (ORR)
Time frame: Approximately 18 months
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria
safety(Adverse Events)
Time frame: From the day the patient signs informed consent form until 30 days after last dose of sintilimab
Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)
quality of life（the patient report outcome）
Time frame: From the day the patient received treatment until 30 days after last dose of sintilimab
Each patient answers to specific questions in questionnaire The time frame of most questions is "How would you rate your quality fo life during the last month"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 41056950Lin X, Deng H, Fang N, Chen L, Chen R, Xie X, Xie Z, Zhang J, Liu M, Liu L, Sun N, Wang F, Yang Y, Lv X, Zhang Z, Cai S, Hou T, Li S, He J, Zhou C. Sintilimab plus chemotherapy for first-line treatment of advanced pulmonary lymphoepithelioma-like carcinoma: Phase 2 trial. Cell Rep Med. 2025 Oct 21;6(10):102398. doi: 10.1016/j.xcrm.2025.102398. Epub 2025 Oct 6.
- Individual participant dataSharing planned: No
Related trials for Primary Pulmonary Lymphoepithelioma-like Carcinoma
RecruitingObservational study
The Chinese Pulmonary Lymphoepithelioma-like Carcinoma Collaboration Study
Primary Pulmonary Lymphoepithelioma-like Carcinoma
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. This study is not recruiting at the moment.
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 Sintilimab combined with Gemcitabine and Carboplatin in people with Primary Pulmonary Lymphoepithelioma-like Carcinoma and Lung Cancer, run by Zhou Chengzhi 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng zhi Zhou (13560351186, doctorzcz@163.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: Approximately 18 months). 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?
On the ClinicalTrials.gov record for NCT04312204, which also lists 1 linked publication.
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 18 Mar 2020.