Table 1.
Completed and ongoing clinical trials assessing STAT3 pathway inhibition in NSCLC; Source: ClinicalTrials.gov.
| Compound (s) | NCT Identifier | Patient Characteristics | Phase | Status/Result |
|---|---|---|---|---|
| Siltuximab a | NCT00841191 | Advanced solid cancers including anti-EGFR therapy resistant NSCLC |
Phase 1/2 | Completed, no clinical benefit |
| ALD518 a | NCT00866970 | Advanced NSCLC | Phase 2 | Completed, reduction of anemia/cachexia |
| AZD1480 b | NCT01112397 | Advanced solid cancers including EGFR or ROS-mutant NSCLC |
Phase 1 | Completed, no clinical benefit |
| Ruxolitinib b + Pemetrexed/ Cisplatin d |
NCT02119650 | Advanced or recurrent NSCLC without targetable driver mutations | Phase 2 | Completed, no clinical benefit |
| Ruxolitinib b + Erlotinib d |
NCT02155465 | Advanced EGFR-mutant + EGFR-TKI resistant (including EGFR T790M) NSCLC | Phase 1/2 | Completed, no clinical benefit |
| Ruxolitinib b + Afatinib d |
NCT02145637 | Advanced EGFR-mutant + EGFR-TKI resistant (including EGFR T790M) NSCLC | Phase 1 | Completed, no clinical benefit |
| Momelotinib b + Trametinib d | NCT02258607 | Advanced K-RAS-mutated NSCLC with prior failure to platinum-based chemotherapy | Phase 1 | Completed, no clinical benefit |
| AZD4205 b + Osimertinib d | NCT03450330 | Advanced EGFR-mutant + EGFR-TKI resistant NSCLC | Phase 1/2 | Ongoing, NA |
| Itacitinib b + Osimertinib d |
NCT02917993 | Advanced EGFR-mutant+ EGFR-TKI (including EGFR T790M) resistant NSCLC | Phase 1/2 | Ongoing, NA |
| Itacitinib b + Pembrolizumab d | NCT03425006 | Advanced PD-L1 expressing NSCLC (first-line treatment) | Phase 2 | Ongoing, NA |
| AZD9150 c+ Durvalumab d |
NCT02983578 | Advanced solid cancers including treatment-refractory NSCLC |
Phase 2 | Recruiting, NA |
| AZD9150 c + Durvalumab d |
NCT03334617 | Advanced NSCLC progressed on an anti-PD-1/PD-L1 therapy | Phase 2 | Recruiting, NA |
| AZD9150 c + Durvalumab d,* |
NCT03421353 | Advanced solid cancers including treatment refractory NSCLC |
Phase 1/2 | Ongoing, NA |
a Anti-IL-6 antibody: Siltuximab, ALD518; b JAK-TKIs: AZD1480 (JAK1/2), ruxolitinib (JAK1/2), AZD4205 (JAK1), itacitinib (JAK1), momelotinib (JAK1/2, TBK1); c AZD9150 (STAT3 antisense oligonucleotide); d others: pemetrexed/cisplatin (cytostatic), erlotinib (1st generation EGFR-TKI), afatinib (2nd generation EGFR-TKI); osimertinib (3rd generation EGFR-TKI), trametinib (MEK1/2 inhibitor), pembrolizumab (anti-PD-1 monoclonal antibody), durvalumab (anti-PD-L1 monoclonal antibody);* + chemotherapy, NA: not available.