Table 2.
Published clinical trial outcomes in ALK-rearranged NSCLC
| Clinicaltrials.gov Identifier | Trial | Study drug | Trial Phase | Description | RR (%) | Median PFS (months) |
|---|---|---|---|---|---|---|
| NCT00585195 | PROFILE 1001 [79] | crizotinib | 1/2 | Safety of crizotinib in ALK-rearranged NSCLC, mostly in the second line and beyond | 57 | 9.7 |
| NCT00932451 | PROFILE 1005 [80] | crizotinib | 2 | Activity of crizotinib in ALK-rearranged NSCLC | 53 | 8.5 |
| crizotinib | 3 | Outcomes of ALK-rearranged NSCLC treatment in the second line | 65 | 7.7 | ||
| NCT00932893 | PROFILE 1007 [41] | docetaxel | 3 | Outcomes of ALK-rearranged NSCLC treatment in the second line | 6 | 2.6 |
| pemetrexed | 3 | Outcomes of ALK-rearranged NSCLC treatment in the second line | 29 | 4.2 | ||
| NCT01154140 | PROFILE 1014 [40] | crizotinib | 3 | Outcomes of ALK-rearranged NSCLC treatment in the first line | 74 | 10.9 |
| Platinum-based chemotherapy | 3 | Outcomes of ALK-rearranged NSCLC treatment in the first line | 45 | 7.0 | ||
| NCT01283516 | ASCEND-1 [55, 81] | ceritinib | 1 | Efficacy and safety of ceritinib in ALK-rearranged NSCLC in patients who are ALK inhibitor-naïve | 72% in ALK inhibitor-naïve and 56% in ALK inhibitor-pretreated | 18.4 months in ALK inhibitor-naïve and 6.9 months in ALK inhibitor-pretreated |
| JapicCTI*-101264 | AF-001JP [60] | alectinib | 1/2 | Activity and safety of ceritinib in ALK-rearranged NSCLC in ALK inhibitor-naïve patients | 94 | n/a |
| NCT01801111 | NP28673 trial [82] | alectinib | 2 | Activity of alectinib in crizotinib-refractory ALK-rearranged NSCLC | 50 | 8.9 |
| NCT01871805 | Alectinib in ALK - positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicenter, phase 2 trial [83] | alectinib | 2 | Activity of alectinib in crizotinib-refractory ALK-rearranged NSCLC | 48 | 8.1 |
| JapicCTI*-132316 | J-ALEX [84] | alectinib | 3 | Alectinib versus crizotinib in treatment-naive ALK rearranged advanced NSCLC | Not reported | Not reached; PFS HR of alectinib arm to crizotinib arm was 0.35 99.6826% CI: 0.17–0.70, stratified log-rank p<0.0001) |
| crizotinib | 3 | Alectinib versus crizotinib in treatment-naive ALK rearranged advanced NSCLC | Not reported | 10.2 | ||
| NCT01449461 | Safety and efficacy of brigatinib (AP26113) in advanced malignancies, including ALK+ non–small cell lung cancer (NSCLC) [85]. | brigatinib | 1/2 | Safety and efficacy of brigatinib in ALK rearranged NSCLC | 74 (69 in crizotinib-treated subset and 100 in crizotinib-naïve subset) | 14 (11.8 in crizotinib-pre-treated subset) |
| NCT00431015 | Activity of IPI-504, a Novel Heat-Shock Protein 90 Inhibitor, in Patients With Molecularly Defined Non–Small-Cell Lung Cancer [66, 86] | IPI-504 | 2 | Activity of IPI-504 in molecularly defined NSCLC | only 3 patients (partial response in 2 and stable disease in 1) | n/a |
| NCT01031225 | A Multicenter Phase II Study of Ganetespib Monotherapy in Patients with Genotypically Defined Advanced Non–Small Cell Lung Cancer [67] | ganetespib | 2 | Activity and tolerability of ganetespib in the second line in NSCLC | 50 | 8.1 |
*
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Abbreviations: ALK, anaplastic lymphoma kinase; NSCLC, non-small cell lung cancer