Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07365241 | A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer | PHASE3 | NOT YET_RECRUITING | 531 | — | — | Apr 14, 2026 | Sep 1, 2030 | Jan 26, 2026 | - | — |
| NCT07155174 | A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer | PHASE2 | RECRUITING | 180 | — | — | Nov 25, 2025 | Sep 1, 2031 | May 18, 2026 | 49 | United States, Belgium +9 |
OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR)/partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by BICR assessment prior to initiation of subsequent anti-cancer therapy. OR will be summarized by ORR, defined as the percentage of participants achieving OR and will be summarized for each arm with its associated 95% confidence interval (CI).
OS is defined as the time from the date of randomization to the date of death of any cause.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| ABBV-706 | EXPERIMENTAL | Participants will receive ABBV-706 as part of the 53 month study duration. |
| Stand of Care (SOC) | ACTIVE_COMPARATOR | Participants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration. |
| Safety Lead-In: ABBV-706 Dose A | EXPERIMENTAL | Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Safety Lead-In: ABBV-706 Dose B | EXPERIMENTAL | Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Safety Lead-In: Stand of Care (SOC) | EXPERIMENTAL | Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration. |
| Expansion: ABBV-706 Dose A | EXPERIMENTAL | Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Expansion: ABBV-706 Dose B | EXPERIMENTAL | Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Expansion: SOC | EXPERIMENTAL | Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-706 | DRUG | Intravenous (IV) Infusion |
| Topotecan | DRUG | IV Infusion |
| Lurbinectedin | DRUG | IV Infusion |
| Amrubicin | DRUG | IV Infusion |
| Atezolizumab | DRUG | IV Infusion |
| Etoposide | DRUG | IV Infusion |
| Carboplatin | DRUG | IV Injection |
Inclusion Criteria: * Diagnosis of histologically or cytologically confirmed Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC). * Participants must have progressed on prior systemic therapy, with CPI (if eligible) and prior tarlatamab, defined as: * In the 1L and 2L setting respectively, p...