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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05565378 | A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 351 | — | — | Oct 14, 2022 | Feb 26, 2027 | Jan 8, 2026 | 99 | United States, Argentina +20 |
| NCT06405230 | Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC) | PHASE1 | RECRUITING | 40 | — | — | Dec 30, 2025 | Oct 10, 2029 | Feb 3, 2026 | 1 | United Kingdom |
The primary endpoint is the correlation between "treatment-induced change in PDL1 in PDOs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" AND/OR "treatment-induced change in PDL1 in EVs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" and "changes in PET which will be evaluated as the percentage difference in PDL1-PET standard uptake volume (SUV) uptake in lesions from the baseline to on-treatment" using the formula for Spearman's rank correlation coefficient. The Spearmans rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect positive association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab Monotherapy | ACTIVE_COMPARATOR | Participants will be administered with pembrolizumab as monotherapy in a fixed dose. |
| Dostarlimab Monotherapy | EXPERIMENTAL | Participants will be administered with dostarlimab as monotherapy in a fixed dose. |
| Substudy 1A | EXPERIMENTAL | Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A). |
| Substudy 1B | EXPERIMENTAL | Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B). |
| Substudy 1C | EXPERIMENTAL | Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C). |
| Substudy 2A | EXPERIMENTAL | Participants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug |
| Pembrolizumab ± Platinum-based chemotherapy doublet (PBCD) | EXPERIMENTAL | Participants will receive pembrolizumab with or without PBCD. |
| Dostarlimab ± PBCD | EXPERIMENTAL | Participants will receive dostarlimab with or without PBCD. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Pembrolizumab will be administered. |
| Dostarlimab | DRUG | Dostarlimab will be administered |
| Belrestotug | DRUG | Belrestotug will be administered. |
| Nelistotug | DRUG | Nelistotug will be administered. |
| Pemetrexed+ (carboplatin or cisplatin) | DRUG | PBCD consisting of pemetrexed+ (carboplatin or cisplatin) will be administered. |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous) * No prior systemic therapy for their locally...