Advanced Lung CarcinomaPhase 2/3NCT04702009
Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy and Bronchoscopy-assisted Interventional Therapy in Patients With Advanced Central Non-small Cell Lung Cancer
A Phase 2/3 study testing Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy in people with Advanced Lung Carcinoma and Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Lung cancer is one of the malignant tumors with high morbidity and mortality. Several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced 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
- Advanced Lung Carcinoma, Non-small Cell Lung Cancer
- What is being tested?
- Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2021to 20 Jan 2026
- Phase
- Phase 2/3
- 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) Patients volunteer to participate in clinical studies and sign an informed consent (ICF), and are willing to follow and able to complete all trial procedures.
- 2)18-75 years of age 3) All patients included are diagnosed with lung cancer detected by fibrous bronchoscope or percutaneous lung puncture biopsy, and are confirmed as NSCLC by Immunohistochemistry.
- 4) Obstruction-type central lung cancer that cannot be surgically removed. 5) Patients without EGFR, ALK, and ROS mutation. 6) Patients have not previously received systemic treatment for phase IV NSCLC or patients receiving the adjuvant or neoadjuvant therapy for more than 6 months before the diagnosis of phase IV NSCLC.
- 7) Within 4 weeks, at least one measurable lesions are required for researchers to evaluate in accordance with RECIST 1.1 requirements.
- 8) Appropriate tumor tissues for PD-L1 expression level determination are required.
- 9) Relevant laboratory tests indicate tolerance for chemotherapy, immunotherapy, and bronchoscopy.
Who cannot join
- Patients with uncertain diagnosis.
- Non-central NSCLC patients.
- Patients with contraindications to chemotherapy or immunotherapy.
- Bronchoscopy is contraindicated in patients.
- Patients have other active malignancies. Patients with cured limited tumors, such as skin substrate cell carcinoma, skin squamous cancer, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situ of cervix, and breast in-place cancer, can be included.
- Patients with human immunodeficiency virus (HIV) infection.
Show all 11Show fewer
- Patients with infection of active tuberculosis.
- Patients have received a live vaccines within 28 days of the first drug use. Patients receiving inactivated viral vaccines to treat seasonal influenza are allowed, but inactivated live influenza vaccines with intracn nasal drugs are not allowed.
- Pregnant or lactating women.
- Patients have a known history of psychosophedic substance abuse or drug abuse;
- The researchers determined that there may be other factors that might have contributed to the early termination of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai pulmonary hospital, Tongji University
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy vs. Anti-PD-1/PD-L1 Monoclonal Antibody, Chemotherapy, in Combination With Bronchoscopy-assisted Interventional Therapy in the Treatment of Patients With Advanced Central Non-small Cell Lung Cancer, a Randomized Controlled, Prospective Clinical Trial
Lung cancer is one of the malignant tumors with high morbidity and mortality. Several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced non-small cell lung cancer (NSCLC). However, its overall effective population is only 20%, and even in studies of enriched populations (such as PD-L1 ≥ 50%), its single-drug effective rate is only about 40%. Therefore, this study aims to explore the efficacy and safety of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted lnterventional therapy in the first-line treatment of advanced central non-small cell lung cancer. We conducted a randomized controlled, prospective clinical trial to examine the efficacy, safety, and mechanism of anti-PD-1/PD-L1 monoclonal antibodies, chemotherapy, in combination with bronchoscopy-assisted interventional therapy vs anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.
Read the detailed description
Lung cancer is one of the malignant tumors with high morbidity and mortality. Most patients with lung cancers are already in advanced stages when diagnosed, and the 5-year survival rate of advanced lung cancer is less than 5%. Therefore, exploring effective treatments is of great significance for improving the survival and quality of life of patients with lung cancer. Immunotherapy represented by immune checkpoint inhibitors has received widespread attention in the field of lung cancer, and several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced non-small cell lung cancer (NSCLC).However, its overall effective population is only 20%, even in studies of enriched populations (such as PD-L1 ≥ 50%), its single-drug effective rate is only about 40%. Therefore, this study aims to explore the efficacy and safety of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted interventional therapy in the first-line treatment of advanced central non-small cell lung cancer. We conducted a randomized controlled, prospective clinical trial to examine the efficacy, safety and mechanism of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted interventional therapy versus anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.
- Being tested
- Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based 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.
Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet ChemotherapyDrug
CIT (chemoimmunotherapy): anti-PD-1 sintilimab (Tyvyt) 200 mg IV on Day 1 q3w combined with platinum-based doublet chemotherapy at standard label doses selected by histology (squamous: gemcitabine + cisplatin/carboplatin or taxane + carboplatin; nonsquamous: pemetrexed + cisplatin/carboplatin). Treatment q3w for 4-6 cycles, then maintenance sintilimab ± pemetrexed until progression, unacceptable toxicity, consent withdrawal, or investigator decision. Dose modifications per labels/protocols; irAEs managed per guidelines (hold sintilimab, corticosteroids as indicated).
Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet ChemotherapyProcedure or surgery
BIT: therapeutic flexible bronchoscopy with endobronchial tumor debulking performed exclusively with high-frequency electrocautery within 14 days after randomization (once before CIT or twice: before CIT and before Cycle 3). Performed under monitored anesthesia care (propofol-based deep sedation) or general anesthesia with airway control; topical lidocaine as needed. Electrocautery delivered via ES-300D electrosurgical generator (Beijing Taktvoll; monopolar cutting); energy individualized per lesion/manufacturer guidance. Goal: restore airway patency and relieve obstruction symptoms while minimizing bleeding/hypoxemia. Self-expanding tracheobronchial stent (Micro-Tech, Nanjing) placed when clinically indicated. No APC/cryotherapy/laser or other adjuncts. Continuous ECG, SpO2 and NIBP monitoring; complications recorded.
| Study group | Role | What they receive |
|---|---|---|
| CIT alone | Active comparator | Participants randomized to CIT alone received standard first-line chemoimmunotherapy (CIT) per protocol (see Intervention description). Receives: Drug: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy |
| BIT + CIT | Experimental | Participants randomized to BIT+CIT underwent bronchoscopic intervention therapy (BIT) within 14 days after randomization (either 1 session before CIT initiation or 2 sessions: before CIT and before Cycle 3), followed by first-line CIT. BIT consisted of therapeutic flexible bronchoscopy with endobronchial tumor debulking using high-frequency electrocautery; airway stent could be placed if clinically indicated. CIT was administered per protocol (see Intervention description). Receives: Drug: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy; Procedure: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
To evaluate the progression free survival (PFS) in the first-line treatment of patients with advanced central NSCLC
Measured: 1 year
Secondary outcomes (5)
objective response rate (ORR)
To evaluate the objective response rate (ORR) in the first-line treatment of patients with advanced central NSCLC
Measured: 6 weeks
disease control rate (DCR)
To evaluate the disease control rate (DCR) in the first-line treatment of patients with advanced central NSCLC
Measured: 6 weeks
overall survival (OS)
To evaluate the overall survival (OS) in the first-line treatment of patients with advanced central NSCLC
Measured: 2 years
Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v5.0
To evaluate the side effects in the first-line treatment of patients with advanced central NSCLC
Measured: 2 years
quality of life (QoL)
To evaluate the quality of life (QoL) in the first-line treatment of patients with advanced central NSCLC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start20 Jan 2021
- Primary completion17 Oct 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Advanced Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yayi He, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702009
- Sponsor's protocol ID
- 2021HY017
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2021
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication, limited to the variables necessary to reproduce the reported analyses, will be made available to qualified researchers upon reasonable request. A data dictionary, study protocol, and statistical analysis plan will also be available. No direct participant identifiers will be shared.
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902He Y, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Yu H, Zhou C, Hirsch FR. MHC class II expression in lung cancer. Lung Cancer. 2017 Oct;112:75-80. doi: 10.1016/j.lungcan.2017.07.030. Epub 2017 Jul 29.
PubMed 29191604He Y, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Yu H, Zhou C, Hirsch FR. PD-1, PD-L1 Protein Expression in Non-Small Cell Lung Cancer and Their Relationship with Tumor-Infiltrating Lymphocytes. Med Sci Monit. 2017 Mar 9;23:1208-1216. doi: 10.12659/msm.899909.
PubMed 28275222Deng J, Zhao S, Zhang X, Jia K, Wang H, Zhou C, He Y. OX40 (CD134) and OX40 ligand, important immune checkpoints in cancer. Onco Targets Ther. 2019 Sep 6;12:7347-7353. doi: 10.2147/OTT.S214211. eCollection 2019.
PubMed 31564917He Y, Yu H, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Suda K, Ren S, Wu C, Hou L, Zhou C, Hirsch FR. LAG-3 Protein Expression in Non-Small Cell Lung Cancer and Its Relationship with PD-1/PD-L1 and Tumor-Infiltrating Lymphocytes. J Thorac Oncol. 2017 May;12(5):814-823. doi: 10.1016/j.jtho.2017.01.019. Epub 2017 Jan 26.
PubMed 28132868He Y, Jia K, Dziadziuszko R, Zhao S, Zhang X, Deng J, Wang H, Hirsch FR, Zhou C. Galectin-9 in non-small cell lung cancer. Lung Cancer. 2019 Oct;136:80-85. doi: 10.1016/j.lungcan.2019.08.014. Epub 2019 Aug 16.
PubMed 31454748
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy vs. Anti-PD-1/PD-L1 Monoclonal Antibody, Chemotherapy, in Combination With Bronchoscopy-assisted Interventional Therapy in the Treatment of Patients With Advanced Central Non-small Cell Lung Cancer, a Randomized Controlled, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04702009
- Acronym / sponsor ID
- 2021HY017
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 8 Jan 2021 (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.
Lung cancer is one of the malignant tumors with high morbidity and mortality. Several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced non-small cell lung cancer (NSCLC). However, its overall effective population is only 20%, and even in studies of enriched populations (such as PD-L1 ≥ 50%), its single-drug effective rate is only about 40%. Therefore, this study aims to explore the efficacy and safety of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted lnterventional therapy in the first-line treatment of advanced central non-small cell lung cancer. We conducted a randomized controlled, prospective clinical trial to examine the efficacy, safety, and mechanism of anti-PD-1/PD-L1 monoclonal antibodies, chemotherapy, in combination with bronchoscopy-assisted interventional therapy vs anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.
Detailed description
Lung cancer is one of the malignant tumors with high morbidity and mortality. Most patients with lung cancers are already in advanced stages when diagnosed, and the 5-year survival rate of advanced lung cancer is less than 5%. Therefore, exploring effective treatments is of great significance for improving the survival and quality of life of patients with lung cancer. Immunotherapy represented by immune checkpoint inhibitors has received widespread attention in the field of lung cancer, and several PD-1/PD-L1 immune checkpoint inhibitors have been approved for the treatment of advanced non-small cell lung cancer (NSCLC).However, its overall effective population is only 20%, even in studies of enriched populations (such as PD-L1 ≥ 50%), its single-drug effective rate is only about 40%. Therefore, this study aims to explore the efficacy and safety of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted interventional therapy in the first-line treatment of advanced central non-small cell lung cancer. We conducted a randomized controlled, prospective clinical trial to examine the efficacy, safety and mechanism of anti-PD-1/PD-L1 monoclonal antibodies and chemotherapy in combination with bronchoscopy-assisted interventional therapy versus anti-PD-1/PD-L1 monoclonal antibody in combination with chemotherapy as the first-line treatment of patients with advanced central NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIT alone | Active comparator | Drug: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet ChemotherapyParticipants randomized to CIT alone received standard first-line chemoimmunotherapy (CIT) per protocol (see Intervention description). |
| BIT + CIT | Experimental | Drug: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy, Procedure: Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet ChemotherapyParticipants randomized to BIT+CIT underwent bronchoscopic intervention therapy (BIT) within 14 days after randomization (either 1 session before CIT initiation or 2 sessions: before CIT and before Cycle 3), followed by first-line CIT. BIT consisted of therapeutic flexible bronchoscopy with endobronchial tumor debulking using high-frequency electrocautery; airway stent could be placed if clinically indicated. CIT was administered per protocol (see Intervention description). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1) Patients volunteer to participate in clinical studies and sign an informed consent (ICF), and are willing to follow and able to complete all trial procedures.
- 2)18-75 years of age 3) All patients included are diagnosed with lung cancer detected by fibrous bronchoscope or percutaneous lung puncture biopsy, and are confirmed as NSCLC by Immunohistochemistry.
- 4) Obstruction-type central lung cancer that cannot be surgically removed. 5) Patients without EGFR, ALK, and ROS mutation. 6) Patients have not previously received systemic treatment for phase IV NSCLC or patients receiving the adjuvant or neoadjuvant therapy for more than 6 months before the diagnosis of phase IV NSCLC.
- 7) Within 4 weeks, at least one measurable lesions are required for researchers to evaluate in accordance with RECIST 1.1 requirements.
- 8) Appropriate tumor tissues for PD-L1 expression level determination are required.
Key exclusion criteria (11 listed)
- Patients with uncertain diagnosis.
- Non-central NSCLC patients.
- Patients with contraindications to chemotherapy or immunotherapy.
- Bronchoscopy is contraindicated in patients.
- Patients have other active malignancies. Patients with cured limited tumors, such as skin substrate cell carcinoma, skin squamous cancer, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situ of cervix, and breast in-place cancer, 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 |
|---|---|---|
| Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet ChemotherapyCIT (chemoimmunotherapy): anti-PD-1 sintilimab (Tyvyt) 200 mg IV on Day 1 q3w combined with platinum-based doublet chemotherapy at standard label doses selected by histology (squamous: gemcitabine + cisplatin/carboplatin or taxane + carboplatin; nonsquamous: pemetrexed + cisplatin/carboplatin). Treatment q3w for 4-6 cycles, then maintenance sintilimab ± pemetrexed until progression, unacceptable toxicity, consent withdrawal, or investigator decision. Dose modifications per labels/protocols; irAEs managed per guidelines (hold sintilimab, corticosteroids as indicated). | Drug | BIT + CIT, CIT alone |
| Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet ChemotherapyBIT: therapeutic flexible bronchoscopy with endobronchial tumor debulking performed exclusively with high-frequency electrocautery within 14 days after randomization (once before CIT or twice: before CIT and before Cycle 3). Performed under monitored anesthesia care (propofol-based deep sedation) or general anesthesia with airway control; topical lidocaine as needed. Electrocautery delivered via ES-300D electrosurgical generator (Beijing Taktvoll; monopolar cutting); energy individualized per lesion/manufacturer guidance. Goal: restore airway patency and relieve obstruction symptoms while minimizing bleeding/hypoxemia. Self-expanding tracheobronchial stent (Micro-Tech, Nanjing) placed when clinically indicated. No APC/cryotherapy/laser or other adjuncts. Continuous ECG, SpO2 and NIBP monitoring; complications recorded. | Procedure or surgery | BIT + CIT |
Primary outcome
progression free survival (PFS)
Time frame: 1 year
To evaluate the progression free survival (PFS) in the first-line treatment of patients with advanced central NSCLC
5 secondary outcomes
objective response rate (ORR)
Time frame: 6 weeks
disease control rate (DCR)
Time frame: 6 weeks
overall survival (OS)
Time frame: 2 years
Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v5.0
Time frame: 2 years
quality of life (QoL)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 29191604He Y, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Yu H, Zhou C, Hirsch FR. MHC class II expression in lung cancer. Lung Cancer. 2017 Oct;112:75-80. doi: 10.1016/j.lungcan.2017.07.030. Epub 2017 Jul 29.
- Background: PubMed 28275222He Y, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Yu H, Zhou C, Hirsch FR. PD-1, PD-L1 Protein Expression in Non-Small Cell Lung Cancer and Their Relationship with Tumor-Infiltrating Lymphocytes. Med Sci Monit. 2017 Mar 9;23:1208-1216. doi: 10.12659/msm.899909.
- Background: PubMed 31564917Deng J, Zhao S, Zhang X, Jia K, Wang H, Zhou C, He Y. OX40 (CD134) and OX40 ligand, important immune checkpoints in cancer. Onco Targets Ther. 2019 Sep 6;12:7347-7353. doi: 10.2147/OTT.S214211. eCollection 2019.
- Background: PubMed 28132868He Y, Yu H, Rozeboom L, Rivard CJ, Ellison K, Dziadziuszko R, Suda K, Ren S, Wu C, Hou L, Zhou C, Hirsch FR. LAG-3 Protein Expression in Non-Small Cell Lung Cancer and Its Relationship with PD-1/PD-L1 and Tumor-Infiltrating Lymphocytes. J Thorac Oncol. 2017 May;12(5):814-823. doi: 10.1016/j.jtho.2017.01.019. Epub 2017 Jan 26.
- Background: PubMed 31454748He Y, Jia K, Dziadziuszko R, Zhao S, Zhang X, Deng J, Wang H, Hirsch FR, Zhou C. Galectin-9 in non-small cell lung cancer. Lung Cancer. 2019 Oct;136:80-85. doi: 10.1016/j.lungcan.2019.08.014. Epub 2019 Aug 16.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication, limited to the variables necessary to reproduce the reported analyses, will be made available to qualified researchers upon reasonable request. A data dictionary, study protocol, and statistical analysis plan will also be available. No direct participant identifiers will be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chemoimmunotherapy (CIT): Sintilimab + Platinum-Based Doublet Chemotherapy in people with Advanced Lung Carcinoma and Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 21 Jul 2026. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: 1 year). 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 NCT04702009, which also lists 6 linked publications.
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 21 Jul 2026.