Metastatic NSCLC Clinical Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. - 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. Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Barbee 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 — View Citation
Bray 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. Epu — View Citation
Gandhi L, Rodríguez-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, — View Citation
Jiang 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 — View Citation
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. Review. — View Citation
Travis 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 Organizati — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Object response rate (ORR) | Containing the incidence of complete response (CR) and partial response (PR). | Time Frame: Up to 24 moths. | |
Secondary | Progression-free survival (PFS) | From allocation to first disease progression confirmed by imaging modalities or all cause death, whichever occurs first. | Up to 24 months. | |
Secondary | Disease control rate (DCR) | Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD). | Up to 24 months. | |
Secondary | Duration of Remission (DOR) | The time interval from disease remission to disease progression or death (whichever occurs first). | Up to 24 months. | |
Secondary | Overall survival (OS) | From allocation to any cause death or last follow-up. | Up to 24 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01438307 -
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT05091190 -
Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Lung and Head and Neck Cancers
|
N/A | |
Recruiting |
NCT04170634 -
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
|
||
Recruiting |
NCT05339568 -
Patient's Whole Process Follow-up Management(HOPE-1)
|
||
Recruiting |
NCT05255302 -
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
|
Phase 2/Phase 3 | |
Withdrawn |
NCT04615884 -
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients
|
N/A | |
Recruiting |
NCT05480865 -
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
|
Phase 1 | |
Terminated |
NCT03417882 -
GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC
|
Phase 2 | |
Recruiting |
NCT03589339 -
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
|
Phase 1 | |
Suspended |
NCT05617313 -
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT05403385 -
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT06159790 -
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|
Phase 3 |