Table 3.
Emerging Strategies in ES-SCLC
| Trial | Phase | N | Patients | Treatment | Endpoint | ORR (%) | mPFS (Months) | mOS (Months) | Result of Trial |
|---|---|---|---|---|---|---|---|---|---|
| Anti-TIGIT antibody | |||||||||
| SKYSCRAPER-02 | III | 490 | First-line | CE + Atezolizumab + Tiragolumab | PFS, OS | 70.8 | 5.4 (HR 1.11; P = 0.35) | 13.6 (HR 1.04, P = 0.79) | Negative |
| CE + Atezolizumab + Placebo | 65.6 | 5.6 | 13.6 | ||||||
| Anti-LAG3 antibody | |||||||||
| NCT03365791 | II | 76 | Solid and hematologic malignancies, second- to sixth-line | PDR001 (anti-PD-1 antibody) + LAG525 (anti-LAG3 antibody) | CBR at 24 Weeks | Ongoing | |||
| Anti-4-1BB antibody | |||||||||
| NCT02554812 | Ib/II | 409 | Solid tumor | Avelumab + Utomilumab | DLT, ORR | Ongoing | |||
| PARP inhibitor | |||||||||
| ECOG-ACRIN 2511 | II | 128 | First-line | PE + Veliparib | PFS | 71.9 | 6.1 (HR = 0.63; P = 0.01) | 10.3 (HR = 0.83; P = 0.17) | Positive |
| PE + Placebo | 65.6 | 5.5 | 8.9 | ||||||
| NCT02484404 | II | 20 | Relapsed | Olaparib + Durvalumab | ORR | 10.5 | 1.8 (95% CI, 0.9–2.4) | 4.1 (95% CI, 2.4–9.2) | – |
| SWOG S1929 (NCT04334941) | II | 106 | SLFN11 positive, Maintenance following chemotherapy + Atezolizumab | Atezolizumab + Talazoparib | PFS | 12 | 4.2 (HR 0.70; P = 0.056) | 9.4 (HR 1.17; P = 0.30) | Positive |
| Atezolizumab | 16 | 2.8 | 8.5 | ||||||
| DLL3 targeted agent | |||||||||
| TAHOE | III | 444 | Second-line | Rova-T (antibody drug conjugate) | ORR | 15 | 3.0 (95% CI: 2.9–3.6) | 6.3 (95% CI, 5.6–7.3) | Negative |
| Topotecan | 21 | 4.3 (95% CI: 3.8–5.4) | 8.6 (95% CI: 7.7–10.1) | ||||||
| NCT03319940 | I | 107 | Relapsed | Tarlatamab, AMG757 (BiTE) | Safety | 23.4 | 3.7 (95% CI, 2.1–5.4) | 13.2 (95% CI, 10.5-not reached) | – |
| DeLLphi-301 | II | 222 | Third-line or later | Tarlatamab, AMG757 (BiTE) | ORR | Ongoing | |||
| NCT03392064 | I | 6 | Relapsed | AMG119 (CAR-T) | Safety | Ongoing | |||
| Liposomal Irinotecan | |||||||||
| RESILIENT part 1 | II | 30 | Second-line | Liposomal Irinotecan | Safety | 44 | 3.98 (95% CI, 1.45–4.24) | 8.08 (95% CI, 5.16–9.82) | – |
| RESILIENT part 2 | III | 450 | Second-line | Liposomal Irinotecan | OS | Ongoing | |||
| Topotecan | |||||||||
| Angiogenesis inhibitor | |||||||||
| ALTER1202 | II | 120 | Third-line or later | Anlotinib | PFS | 4.9 | 4.1 (HR 0.19, P< 0.0001) | 7.3 (HR 0.53, P =.0029) | Positive |
| Placebo | 2.6 | 0.7 | 4.9 |
Abbreviations: ORR, objective response rate; PFS, progression free survival; OS, overall survival; HR, hazard ratio; CI, confidence interval; CE, carboplatin + etoposide; PE, cisplatin + etoposide; Rova-T, Rovalpituzumab tesirine; BiTE, bispecific T-cell engager; CAR-T, chimeric antigen receptor-T cell; CBR, clinical benefit rate.