Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
inupadenant · 2 trials · 3 indications
Incidence of dose-limiting toxicities
Incidence of adverse events (AEs), serious adverse events, AEs leading to discontinuation, deaths, and clinically significant laboratory abnormalities.
Time from first dose to the date of first documented radiologic progression per RECIST v1.1 or time of death, whichever comes first
Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities
To assess safety and tolerability as measured by incidence and severity of AEs
| Arm | Type | Description |
|---|---|---|
| Part 1, open label | EXPERIMENTAL | Inupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D). |
| Part 2, active treatment | EXPERIMENTAL | Treatment with inupadenant combined with carboplatin and pemetrexed |
| Part 2, placebo | PLACEBO_COMPARATOR | Treatment with matched placebo combined with carboplatin and pemetrexed |
| Inupadenant sequential dose escalation (Part 1A) | EXPERIMENTAL | Part 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors. |
| Inupadenant randomized crossover (Part 1B) | EXPERIMENTAL | The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors. |
| Inupadenant single treatment assignment (Part 1C) | EXPERIMENTAL | Part 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors. |
| Name | Type | Description |
|---|---|---|
| inupadenant | DRUG | Adenosine 2a receptor antagonist |
| Placebo | DRUG | matched placebo capsule to inupadenant |
| Carboplatin | DRUG | standard of care chemotherapeutic, alkylating agent |
| Pemetrexed | DRUG | standard of care chemotherapeutic, anti-metabolite |
Inclusion Criteria: * Confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable (Stage III) NSCLC of nonsquamous pathology * Measurable disease as defined by RECIST v1.1 * PD-L1 expression status available at or after the time of diagnosis. All levels of expression are eligible...