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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06284317 | A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. | PHASE3 | RECRUITING | 290 | — | — | Jan 15, 2025 | Mar 1, 2030 | Mar 16, 2026 | 42 | Australia, Austria +8 |
| NCT04585490 | Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC | PHASE3 | RECRUITING | 48 | — | — | Aug 25, 2021 | Apr 1, 2028 | May 4, 2026 | 1 | United States |
Assessed in the adjuvant treatment phase. DFS is defined as the time from the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Censoring (for patients without recurrence/death) will occur at the date of last tumour assessment. Patients without a post-randomisation tumour assessment will be censored at the date of randomisation (plus 1 day). DFS will be assessed in patients without pCR (primary endpoint), as well as in patients with pCR (secondary endpoint) and in patients with/without ctDNA clearance (secondary endpoints).
Participants in Cohort 1 MRD+ will be assessed for ctDNA levels at baseline and end of treatment, expected to be 4 cycles of 3 weeks per cycle (defined as ctDNA evaluable set or ctDES). The outcome will be assessed as the number of participants with a ≥ 3 fold decrease in ctDNA level, a number without dispersion.
| Arm | Type | Description |
|---|---|---|
| Durvalumab | EXPERIMENTAL | Protocol treatment in the adjuvant phase consists of adjuvant durvalumab |
| Observation | NO_INTERVENTION | Observation only |
| Cohort 1 minimal residual disease positive (MRD+) | EXPERIMENTAL | Subjects with detectable ctDNA will receive 4 cycles of platinum doublet chemotherapy \[carboplatin/pemetrexed\], tremelimumab (75 mg IV every 21 days) and durvalumab (1500 mg IV every 21 days), except subjects with squamous cell carcinoma histology will receive carboplatin/paclitaxel. Subjects will be evaluated with PET/CT and/or computed tomography (CT) thorax every 12 weeks. Following ctDNA evaluation, in the absence of progression or toxicity, subject will continue with durvalumab to complete 1 year of treatment as standard of care. |
| Cohort 2 minimal residual disease negative (MRD ) | EXPERIMENTAL | Subjects with undetectable ctDNA at study enrollment will receive standard of care durvalumab (10 mg/kg every 2 weeks, or equivalent, for 1 year). If subjects in Cohort 2 MRD progress prior to close of study, blood will be drawn for ctDNA testing. |
| Name | Type | Description |
|---|---|---|
| Adjuvant durvalumab | DRUG | Durvalumab is given at a fixed dose of 1500 mg i.v. every 4 weeks (±1 week) until relapse or unacceptable toxicity, for a maximum of 12 cycles after surgery. |
| Durvalumab | DRUG | Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year) |
| Carboplatin | DRUG | Target area under the curve (AUC) not to exceed 750mg on Day 1 of every 21-day cycle |
| Pemetrexed | DRUG | 500mg/m2 on Day 1 of every 21-day cycle |
| Paclitaxel | DRUG | 175mg/m2 on Day 1 of every 21-day cycle |
| Cisplatin | DRUG | Cisplatin (75mg/m2 per institution guidelines) may be substituted for Carboplatin |
| AVENIO ctDNA Surveillance Kit | DEVICE | Roche Sequencing and Life Science kit to detect minimal residue disease (MRD) |
| Tremelimumab | DRUG | not to exceed 75mg IV on Day 1 of every 21-day cycle |
Inclusion Criteria for enrolment: * Histologically confirmed NSCLC. * Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer. Stage III assessment should include samples of lymph nodes at levels 4, bilaterally, and level 7 to rule out stage IIIB N3 disease. T...