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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06908304 | A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC | PHASE3 | RECRUITING | 300 | — | — | Dec 8, 2025 | Dec 31, 2027 | Jan 12, 2026 | 15 | Poland, Romania +2 |
Overall survival as defined as the time from randomization to death from any cause.
| Arm | Type | Description |
|---|---|---|
| THIO + Cemiplimab Arm | EXPERIMENTAL | THIO 60mg, 30-min IV infusions, Days 1-3 (180 mg/Cycle) Cemplimab 350 mg, 30-min IV infusion, Day 5 3-Week Cycle |
| Investigator's choice of single-agent chemotherapy (vinorelbine, gemcitabine, or docetaxel) | ACTIVE_COMPARATOR | Chemotherapy Agent \[1\] Dosing Regimen No. of Subjects (Planned) Option 1: Vinorelbine 30 mg/m2 IV on D1, D8, and D15 Q3W \~150 \[3\] Option 2: Gemcitabine 1250 mg/m2 IV on D1 and D8 Q3W Option 3: Docetaxel 75 mg/m2 IV on D1 Q3W \[2\] Abbreviations: D = day (within a 21-day cycle); IV= intravenous; Q3W=every 3 weeks (21-day cycles) 1. Standard of Care (for example vinorelbine, gemcitabine, or docetaxel chemotherapy, if not previously exposed, per Investigator's Choice) 2. Docetaxel 60-65 mg/m2 permitted based on country-specific approvals. 3. Within the control arm, there are no limits on the number of subjects who can be treated with any of the chemotherapy agents. |
| Name | Type | Description |
|---|---|---|
| 6-Thio-2'-Deoxyguanosine | DRUG | small molecule telomere targeting agent |
| Cemiplimab | DRUG | programmed cell death protein 1 (PD-1) inhibitor |
| Docetaxel | DRUG | Chemotherapy drug; inhibits cell division by stabilizing microtubules. Used for breast, lung, and prostate cancers. |
| Vinorelbine | DRUG | Chemotherapy drug; disrupts microtubule formation, inhibiting cell division. Used for non-small cell lung cancer and breast cancer. |
| Gemcitabine alone | DRUG | Chemotherapy drug; inhibits DNA synthesis. Used for pancreatic, lung, breast, and ovarian cancers. |
Inclusion Criteria: 1. At least 18 years of age at the time of signing the Informed Consent Form (ICF) prior to initiation of any study specific activities/procedures. Disease Characteristics 2. Stage 3b or 4 histologically or cytologically confirmed NSCLC. Note: Stage is determined at the time...