Metastatic NSCLCPhase 2NCT04846452
Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC
A Phase 2 study testing Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin and Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin in people with Metastatic NSCLC and Recurrent NSCLC, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a single-arm, prospective, exploratory clinical study aiming to evaluate the efficacy and safety profile of sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens in advanced or metastatic NSCLC as first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic NSCLC, Recurrent NSCLC, Advanced Non-Small Cell Squamous Lung Cancer
- What is being tested?
- Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin and Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 May 2023
- 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. Voluntary provision of informed consent.
- 2. Males or females aged 18-75.
- 3. Histological or cytologically confirmed NSCLC, metastatic or recurrent (stage IV), non-resectable or radical radio-chemotherapy locally advanced (stage IIIB-IIIC).
- 4. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, or ROS1 gene mutation)
- 5. At least one lesion can be measured by imaging.
- 6. Have not received systemic treatment in the past.
Show all 9Show fewer
- 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- 8. Life expectancy ≥ 3 months.
- 9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.
Who cannot join
- 1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
- 2. Received radiation therapy within 6 weeks.
- 3. Diagnosed with other malignant diseases other than NSCLC within 5 years.
- 4. Have participated in other interventional clinical research treatments now or within 4 weeks.
- 5. Have previously received targeted therapy.
- 6. Received Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs within 2 weeks.
Show all 14Show fewer
- 7. Have active autoimmune diseases requiring systemic treatment within 2 years.
- 8. Received systemic glucocorticoid therapy or immunosuppressive therapy within 7 days.
- 9. Clinically uncontrollable pleural effusion/abdominal effusion.
- 10. Known allogeneic organ transplantation or hematopoietic stem cell transplantation.
- 11. Known to be allergic to study drug.
- 12. Have been vaccinated with the live vaccine within 30 days.
- 13. Pregnant or breastfeeding females.
- 14. Other serious hazards to the safety of patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Lingxiang Liu, Dr., +862568306577, llxlau@163.com
About this study
Official title: Sintilimab Combined With Anlotinib Hydrochloride and Standard Platinum-Containing Dual-Agent Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment: A Single-Arm, Prospective and Exploratory Clinical Study
This is a single-arm, prospective, exploratory clinical study aiming to evaluate the efficacy and safety profile of sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens in advanced or metastatic NSCLC as first-line treatment. Totally 40 patients with negative driver genes (20 patients of squamous cell carcinoma, 20 patients of non-squamous cell carcinoma) are to be enrolled.
Read the detailed description
Sintilimab (200 mg intravenously, once every 3 weeks; Cinda Bio-Suzhou Co., Ltd., Suzhou, Jiangsu, China) and anlotinib hydrochloride (12 mg orally, once daily before breakfast; CTTQ, Lianyungang, Jiangsu, China) are to be administered as first-line therapy in NSCLC. Besides, patients with non-squamous NSCLC will also receive pemetrexed and cisplatin or carboplatin. Meanwhile, patients with squamous NSCLC will also receive albumin paclitaxel and carboplatin. Patients assessing as CR/PR/SD will continue to receive a maintenance treatment after 4-6 cycles of treatment. Patients with non-squamous NSCLC will be treated with sintilimab + anlotinib hydrochloride + pemetrexed chemotherapy regimen while patients with squamous NSCLC will be treated with sintilimab + anlotinib hydrochloride to maintain treatment for 2 years until disease progression, intolerable toxicity, death, and patient request for discontinuation or starting new anti-tumor treatment.
Observations and assessments will be conducted before treatment, on day 7, 21 of cycle 1, on day 21 of cycle 2, every 2 cycles (42 days) during the following cycles, and after treatment. Follow-up for survival status and subsequent antineoplastic therapy data collecting will be performed by telephone interview or face-to-face every 6 weeks after treatment until disease progression, death, or end of the study (whichever occurs first).
This study will be divided into two stages: the safety lead-in period and the preliminary efficacy evaluation period. The first stage is the safety lead-in period. 3 patients with squamous NSCLC and 3 patients with non-squamous NSCLC will be enrolled to evaluate the combined therapy safety. The first 6 patients will continue to be observed from the beginning of the combined treatment until the 6th patient has been treated for 2 cycles (6 weeks). If there are less than or equal to 2 patients with intolerable side effects, they will enter the next stage. A total of 40 patients (20 patients with squamous NSCLC, 20 patients of non-squamous NSCLC) will be enrolled, and the safety and efficacy of the combined treatment will be initially evaluated. All statistics will be analyzed by statistical analysis software (SAS) 9.2 (or higher version). The single-sided 0.05 superiority hypothesis test will be used to test statistics and the comparison between groups will give a 95% confidence interval and p-value.
Efficacy is to be analyzed in the full analysis set (FAS), the response evaluable set (RES), and the per-protocol set (PPS). Safety is to be analyzed in safety set (SS) including all assigned patients who receive at least one dose of study combined therapy and have safety records of medication. Statistical descriptions of subject distribution, demographic data, and baseline characteristics will be performed. For study endpoints, the Kaplan-Meier method is to be applied for the PFS and OS curve with estimation for median PFS, median OS, and 95% CI. ORR= (CR+PR) / sample size×100%; DCR= (CR+PR+SD) / sample size×100%. The 95% CI of the ORR and DCR is to be calculated by an exact binomial method based on the F distribution. For safety analysis, only treatment-emergent adverse events (TEAE) will be included and analyzed in this experiment, which is defined as AEs that are post-dose or heavier than the baseline. Medical Dictionary for Regulatory Activities (MedDRA), system organ class (SOC), preferred terms (PT) and NCI CTCAE 5.0 will be used to standardize and classify all adverse events and summarize the incidence of AEs and association with treatments.
- Being tested
- Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin, Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin
- Keywords
- Metastatic NSCLC, Recurrent NSCLC, Advanced NSCLC, Sintilimab, Anlotinib Hydrochloride, Chemotherapy, First-Line Treatment
- 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.
Sintilimab + Anlotinib + Pemetrexed + Cisplatin or CarboplatinDrug
Also called combination therapy
Patients with non-squamous NSCLC will receive sintilimab, anlotinib hydrochloride, pemetrexed, and cisplatin or carboplatin.
Sintilimab + Anlotinib + Albumin Paclitaxel + CarboplatinDrug
Also called combination therapy
Patients with squamous NSCLC will receive sintilimab, anlotinib hydrochloride, albumin paclitaxel, and carboplatin.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients with negative driver genes | Experimental | Patients with negative driver genes advanced or metastatic NSCLC will receive sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens as first-line treatment. Receives: Drug: Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin; Drug: Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Object response rate (ORR)
Containing the incidence of complete response (CR) and partial response (PR).
Measured: Time Frame: Up to 24 moths.
Secondary outcomes (4)
Progression-free survival (PFS)
From allocation to first disease progression confirmed by imaging modalities or all cause death, whichever occurs first.
Measured: Up to 24 months.
Disease control rate (DCR)
Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).
Measured: Up to 24 months.
Duration of Remission (DOR)
The time interval from disease remission to disease progression or death (whichever occurs first).
Measured: Up to 24 months.
Overall survival (OS)
From allocation to any cause death or last follow-up.
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 posted15 Apr 2021
- Study start1 Jun 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
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 Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingxiang Liu, Physician, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846452
- Sponsor's protocol ID
- 2021-SR-088
- Status last verified
- Aug 2021
- First submitted
- 13 Apr 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD and all IPD that underlie results in a publication.
Publications
McDermott DF, Atkins MB. PD-1 as a potential target in cancer therapy. Cancer Med. 2013 Oct;2(5):662-73. doi: 10.1002/cam4.106. Epub 2013 Jul 21.
PubMed 24403232Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630.
PubMed 26291008Barbee MS, Ogunniyi A, Horvat TZ, Dang TO. Current status and future directions of the immune checkpoint inhibitors ipilimumab, pembrolizumab, and nivolumab in oncology. Ann Pharmacother. 2015 Aug;49(8):907-37. doi: 10.1177/1060028015586218. Epub 2015 May 19.
PubMed 25991832Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.
PubMed 29658856Jiang S, Liang H, Liu Z, Zhao S, Liu J, Xie Z, Wang W, Zhang Y, Han B, He J, Liang W. The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303). Oncologist. 2020 May;25(5):e870-e874. doi: 10.1634/theoncologist.2019-0838. Epub 2020 Feb 20.
PubMed 32077550
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Anlotinib Hydrochloride and Standard Platinum-Containing Dual-Agent Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment: A Single-Arm, Prospective and Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT04846452
- Acronym / sponsor ID
- 2021-SR-088
- Keywords
- Metastatic NSCLC, Recurrent NSCLC, Advanced NSCLC, Sintilimab, Anlotinib Hydrochloride, Chemotherapy, First-Line Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 15 Apr 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.
This is a single-arm, prospective, exploratory clinical study aiming to evaluate the efficacy and safety profile of sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens in advanced or metastatic NSCLC as first-line treatment. Totally 40 patients with negative driver genes (20 patients of squamous cell carcinoma, 20 patients of non-squamous cell carcinoma) are to be enrolled.
Detailed description
Sintilimab (200 mg intravenously, once every 3 weeks; Cinda Bio-Suzhou Co., Ltd., Suzhou, Jiangsu, China) and anlotinib hydrochloride (12 mg orally, once daily before breakfast; CTTQ, Lianyungang, Jiangsu, China) are to be administered as first-line therapy in NSCLC. Besides, patients with non-squamous NSCLC will also receive pemetrexed and cisplatin or carboplatin. Meanwhile, patients with squamous NSCLC will also receive albumin paclitaxel and carboplatin. Patients assessing as CR/PR/SD will continue to receive a maintenance treatment after 4-6 cycles of treatment. Patients with non-squamous NSCLC will be treated with sintilimab + anlotinib hydrochloride + pemetrexed chemotherapy regimen while patients with squamous NSCLC will be treated with sintilimab + anlotinib hydrochloride to maintain treatment for 2 years until disease progression, intolerable toxicity, death, and patient request for discontinuation or starting new anti-tumor treatment.
Observations and assessments will be conducted before treatment, on day 7, 21 of cycle 1, on day 21 of cycle 2, every 2 cycles (42 days) during the following cycles, and after treatment. Follow-up for survival status and subsequent antineoplastic therapy data collecting will be performed by telephone interview or face-to-face every 6 weeks after treatment until disease progression, death, or end of the study (whichever occurs first).
This study will be divided into two stages: the safety lead-in period and the preliminary efficacy evaluation period. The first stage is the safety lead-in period. 3 patients with squamous NSCLC and 3 patients with non-squamous NSCLC will be enrolled to evaluate the combined therapy safety. The first 6 patients will continue to be observed from the beginning of the combined treatment until the 6th patient has been treated for 2 cycles (6 weeks). If there are less than or equal to 2 patients with intolerable side effects, they will enter the next stage. A total of 40 patients (20 patients with squamous NSCLC, 20 patients of non-squamous NSCLC) will be enrolled, and the safety and efficacy of the combined treatment will be initially evaluated. All statistics will be analyzed by statistical analysis software (SAS) 9.2 (or higher version). The single-sided 0.05 superiority hypothesis test will be used to test statistics and the comparison between groups will give a 95% confidence interval and p-value.
Efficacy is to be analyzed in the full analysis set (FAS), the response evaluable set (RES), and the per-protocol set (PPS). Safety is to be analyzed in safety set (SS) including all assigned patients who receive at least one dose of study combined therapy and have safety records of medication. Statistical descriptions of subject distribution, demographic data, and baseline characteristics will be performed. For study endpoints, the Kaplan-Meier method is to be applied for the PFS and OS curve with estimation for median PFS, median OS, and 95% CI. ORR= (CR+PR) / sample size×100%; DCR= (CR+PR+SD) / sample size×100%. The 95% CI of the ORR and DCR is to be calculated by an exact binomial method based on the F distribution. For safety analysis, only treatment-emergent adverse events (TEAE) will be included and analyzed in this experiment, which is defined as AEs that are post-dose or heavier than the baseline. Medical Dictionary for Regulatory Activities (MedDRA), system organ class (SOC), preferred terms (PT) and NCI CTCAE 5.0 will be used to standardize and classify all adverse events and summarize the incidence of AEs and association with treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients with negative driver genes | Experimental | Drug: Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin, Drug: Sintilimab + Anlotinib + Albumin Paclitaxel + CarboplatinPatients with negative driver genes advanced or metastatic NSCLC will receive sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens as first-line treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Voluntary provision of informed consent.
- 2. Males or females aged 18-75.
- 3. Histological or cytologically confirmed NSCLC, metastatic or recurrent (stage IV), non-resectable or radical radio-chemotherapy locally advanced (stage IIIB-IIIC).
- 4. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, or ROS1 gene mutation)
- 5. At least one lesion can be measured by imaging.
Key exclusion criteria (14 listed)
- 1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
- 2. Received radiation therapy within 6 weeks.
- 3. Diagnosed with other malignant diseases other than NSCLC within 5 years.
- 4. Have participated in other interventional clinical research treatments now or within 4 weeks.
- 5. Have previously received targeted 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 |
|---|---|---|
| Sintilimab + Anlotinib + Pemetrexed + Cisplatin or CarboplatinAlso: combination therapyPatients with non-squamous NSCLC will receive sintilimab, anlotinib hydrochloride, pemetrexed, and cisplatin or carboplatin. | Drug | NSCLC patients with negative driver genes |
| Sintilimab + Anlotinib + Albumin Paclitaxel + CarboplatinAlso: combination therapyPatients with squamous NSCLC will receive sintilimab, anlotinib hydrochloride, albumin paclitaxel, and carboplatin. | Drug | NSCLC patients with negative driver genes |
Primary outcome
Object response rate (ORR)
Time frame: Time Frame: Up to 24 moths.
Containing the incidence of complete response (CR) and partial response (PR).
4 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 24 months.
Disease control rate (DCR)
Time frame: Up to 24 months.
Duration of Remission (DOR)
Time frame: Up to 24 months.
Overall survival (OS)
Time frame: Up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Background: PubMed 24403232McDermott DF, Atkins MB. PD-1 as a potential target in cancer therapy. Cancer Med. 2013 Oct;2(5):662-73. doi: 10.1002/cam4.106. Epub 2013 Jul 21.
- Results publication: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Results publication: PubMed 26291008Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630.
- Results publication: PubMed 25991832Barbee MS, Ogunniyi A, Horvat TZ, Dang TO. Current status and future directions of the immune checkpoint inhibitors ipilimumab, pembrolizumab, and nivolumab in oncology. Ann Pharmacother. 2015 Aug;49(8):907-37. doi: 10.1177/1060028015586218. Epub 2015 May 19.
- Results publication: PubMed 29658856Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.
- Results publication: PubMed 32077550Jiang S, Liang H, Liu Z, Zhao S, Liu J, Xie Z, Wang W, Zhang Y, Han B, He J, Liang W. The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303). Oncologist. 2020 May;25(5):e870-e874. doi: 10.1634/theoncologist.2019-0838. Epub 2020 Feb 20.
- Individual participant dataSharing planned: Yes. All collected IPD and all IPD that underlie results in a publication.
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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.
Lingxiang Liu, Physician principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 + Anlotinib + Pemetrexed + Cisplatin or Carboplatin and Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin in people with Metastatic NSCLC and Recurrent NSCLC, run by The First Affiliated Hospital with Nanjing Medical University 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 9 inclusion and 14 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 12 Aug 2021. 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 Lingxiang Liu, Physician ((+86) 13851892074, llxlau@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Object response rate (ORR) (time frame: Time Frame: Up to 24 moths.). 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 NCT04846452, 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 12 Aug 2021.