表 1.
肺癌相关的TIGIT临床试验
Clinical trials of TIGIT associated with lung cancer
| Research | Identifier | Medicine | Clinical phase | Target population | Intervening measure | Primary endpoint | Sponsor |
| NSCLC: non-small cell lung cancer; NSQ: advanced non-squamous non-small cell lung cancer; ORR: objective response rate; PFS: progression-free survival; OS: overall survival; CCRT: concurrent radiochemotherapy; ES-SCLC: extensive small cell lung cancer; SBRT: stereotactic ablative radiotherapy; MPR: major pathological response; ITT: intent-to-treat; CRR: complete response rate; CRT: radiochemotherapy; DLT: dose-limiting toxicities; DORR: durable objective response rate; RP2D: recommended phase II dose. | |||||||
| KeyMaker-U01A | NCT04165070 | Vibostolimab | II | Advanced NSCLC (treatment-naive) | Pembrolizumab+Chemotherapy+ Vibostolimab or MK4830 or MK-5890±Pemetrexed (NSQ) | ORR | Merck Sharp & Dohme |
| KEYVIBE-002 | NCT04725188 | MK-7684A (Vibostolimab+Pembrolizumab) | II | Stage IV metastatic NSCLC (after treatment) | MK-7684A±Docetaxel vs Docetaxel | PFS | Merck Sharp & Dohme |
| KEYVIBE -003 | NCT04738487 | MK-7684A (Vibostolimab+Pembrolizumab) | III | PD-L1 (+) metastatic NSCLC | MK-7684A vs Pembrolizumab | PFS; OS | Merck Sharp & Dohme |
| KEYVIBE -006 | NCT05298423 | MK-7684A (Vibostolimab+Pembrolizumab) | III | Stage III NSCLC | MK-7684A+CCRT followed by MK-7684A vs CCRT followed by Durvalumab | PFS; OS | Merck Sharp & Dohme |
| KEYVIBE -007 | NCT05226598 | MK-7684A (Vibostolimab+Pembrolizumab) | III | Metastatic NSCLC | MK-7684A+Chemotherapy vs Pembrolizumab+Chemotherapy | PFS; OS | Merck Sharp & Dohme |
| KEYVIBE -008 | NCT05224141 | MK-7684A (Vibostolimab+Pembrolizumab) | III | ES-SCLC (treatment-naive) | MK-7684A+Chemotherapy vs Atezolizumab+Chemotherapy | OS | Merck Sharp & Dohme |
| SKYROCKET | NCT05034055 | Tiragolumab | II | Metastatic NSCLC (treatment-naive) | SBRT followed by Atezolizumab/Tiragolumab | PFS | Yonsei University |
| SKYSCRAPER-01 | NCT04294810 | Tiragolumab | III | Previously untreated locally advanced unresectable or metastatic PD-L1-selected NSCLC | Atezolizumab+Tiragolumab vs Atezolizumab+Placebo | PFS; OS | Hoffmann-La Roche |
| SKYSCRAPER-02 | NCT04256421 | Tiragolumab | III | Untreated extensive-stage SCLC | Tiragolumab+Atezolizumab +Chemotherapy vs Placebo+ Atezolizumab+Chemotherapy | PFS; OS | Hoffmann-La Roche |
| SKYSCRAPER-02C | NCT04665856 | Tiragolumab | III | Untreated extensive-stage SCLC | Tiragolumab+Atezolizumab+ Chemotherapy vs Placebo+Atezolizumab+Chemotherapy | PFS/OS in the Primary Population | Hoffmann-La Roche |
| SKYSCRAPER-03 | NCT04513925 | Tiragolumab | III | Locally advanced, unresectable stage III NSCLC | Atezolizumab+Tiragolumab vs Durvalumab | PFS | Hoffmann-La Roche |
| SKYSCRAPER-06 | NCT04619797 | Tiragolumab | II/III | Previously untreated advanced NSQ | Tiragolumab+Atezolizumab+Chemotherapy vs Placebo+Pembrolizumab+ Chemotherapy | ORR; PFS; OS | Hoffmann-La Roche |
| GO40290 | NCT03563716 | Tiragolumab | II | Chemotherapy-naive patients with locally advanced or metastatic NSCLCL | Tiragolumab+Atezolizumab | ORR; PFS | Genentech |
| GO42501 | NCT04832854 | Tiragolumab | II | Previously untreated locally advanced resectable stage II, IIIA, or select IIIB NSCLC | Neoadjuvant and adjuvant Tiragolumab+Atezolizumab | Number of participants with surgical delays, operative and post-operative complications, surgical cancellations related to study treatment; Percentage of participants with adverse events; MPR | Hoffmann-La Roche |
| ML41257 | NCT04308785 | Tiragolumab | II | LS-SCLC | CRT followed by Atezolizumab+Tiragolumab vs CRT followed by Atezolizumab+Placebo | PFS of ITT population | Hoffmann-La Roche |
| AdvanTIG-204 | NCT04952597 | Ociperlimab | II | Untreated limited-stage SCLC | Ociperlimab+Tislelizumab+ Chemoradiotherapy | PFS | BeiGene |
| AdvanTIG-205 | NCT05014815 | Ociperlimab | II | Untreated metastatic NSCLC | Ociperlimab+Tislelizumab+Chemotherapy | PFS | BeiGene |
| AdvanTIG-301 | NCT04866017 | Ociperlimab | III | Previously untreated, locally advanced, unresectable NSCLC | Ociperlimab+Tislelizumab+CCRT followed by Ociperlimab+Tislelizumab vs Tislelizumab+CCRT followed by Tislelizumab vs CCRT followed by Durvalumab | PFS/CRR of ITT | BeiGene |
| AdvanTIG-302 | NCT04746924 | Ociperlimab | III | Untreated lung cancer | Tislelizumab+Ociperlimab (Arm A) vs Pembrolizumab+Placebo (Arm B) vs Tislelizumab+Placebo (Arm C) | PFS; OS | BeiGene |
| ARC-7 | NCT04262856 | Domvanalimab (AB-154) | II | PD-L1 positive NSCLC | Zimberelimab vs Zimberelimab+Domvanalimab vs Zimberelimab+Domvanalimab+ Etrumadenant | ORR; PFS | Arcus Biosciences |
| STAR-121 | NCT05502237 | Domvanalimab (AB-154) | III | Untreated metastatic NSCLC | Zimberelimab+Domvanalimab+Chemotherapy vs Pembrolizumab+Chemotherapy | PFS; OS | Gilead Sciences |
| ARC-10 | NCT04736173 | Domvanalimab (AB-154) | III | PD-L1 positive NSCLC | Chemotherapy (Arm A) vs Zimberelimab (Arm B) vs Zimberelimab+Domvanalimab (Arm C) | OS (Arm A vs Arm B, Arm B vs Arm C); PFS (Arm B vs Arm C) | Arcus Biosciences |
| PACIFIC-8 | NCT05211895 | Domvanalimab (AB-154) | III | Stage III unresectable NSCLC | Durvalumab+Domvanalimab vs Durvalumab+Placebo | PFS | Arcus Biosciences |
| CA020-016 | NCT05005273 | BMS-986207 | II | Stage IV NSCLC | Nivolumab+Ipilimumab+BMS-986207 vs Nivolumab+Ipilimumab+Placebo | PFS | Bristol-Myers Squibb |
| Landscape 1011 study | Landscape 1011 study | SEA-TGT | I/II | Advanced NSCLC | Immunotherapy (Sasanlimab) in combination with targeted therapies | DLT; DORR; ORR | Pfizer |
| 213824 | 213824 | EOS-448 | II | PD-L1 high (Tumor cells/tumor proportion score≥50%), previously untreated, unresectable, locally advanced or metastatic NSCLC | GSK4428859A (Pembrolizumab+Dostarlimab) | ORR | Dostarlimab |
| CIBI939A102 (Ia) | NCT04672356 | IBI-939 | I | Advanced lung cancer | IBI939+Sintilimab | Adverse events; RP2D | Innovent Biologics (Suzhou) Co. |
| CIBI939A102 (Ib) | CIBI939A102 (Ib) | IBI-939 | I | Advanced lung cancer | IBI939+Sintilimab | ORR | Innovent Biologics (Suzhou) Co. |