Table 5.
Active ongoing trials of pembrolizumab in NSCLC.
| ClinicalTrials.gov ID | Phase | Treatment arm(s) | Description and objectives |
|---|---|---|---|
| First-line treatment | |||
| NCT01840579 | 1 | – Pembrolizumab – Pembrolizumab + platinum/pemetrexed – Pembrolizumab + CBDCA/paclitaxel – Pembrolizumab + CBDCA/nab-paclitaxel |
Advanced solid tumors and NSCLC – DLT |
| NCT02511184 | 1 | – Pembrolizumab + crizotinib | Advanced ALK+ nonsquamous NSCLC – DLT – ORR, DOR, TTR, PFS, PK |
| NCT02382406 | 1/2 | – Pembrolizumab + CBDCA/nab-paclitaxel | Stage IIIb/IV NSCLC – Safety, tolerability, RP2D, PFS, ORR – OS, PD-L1 expression |
| NCT02039674 | 1/2 | – Pembrolizumab + CBDCA/paclitaxel – Pembrolizumab + CBDCA/paclitaxel/bevacizumab – Pembrolizumab + CBDCA/pemetrexed – Pembrolizumab + ipilimumab – Pembrolizumab + erlotinib/gefitinib |
Stage IIIb/IV NSCLC – ORR, RP2D – OS, PFS, DOR |
| NCT02581943 | 2 | – Pembrolizumab – Pembrolizumab + low-dose CBDCA/paclitaxel |
Stage IIIb/IV NSCLC; PS 2; up to 2 prior
therapies – DOR, ORR, PFS, OS, immune markers |
| NCT02591615 | 2 | – CBDCA/paclitaxel or pemetrexed – Pembrolizumab CBDCA/paclitaxel or pemetrexed |
Stage IV NSCLC – ORR – PFS, safety and tolerability |
| NCT02578680 | 3 | – Platinum/pemetrexed – Pembrolizumab + platinum/pemetrexed |
Advanced nonsquamous NSCLC – PFS per RECIST 1.1 – ORR, OS, PFS per irRECIST |
| NCT02775435 | 3 | – CBDCA + paclitaxel/nab-paclitaxel – Pembrolizumab → CBDCA + paclitaxel/nab-paclitaxel |
Advanced squamous NSCLC – PFS, OS – ORR |
| NCT02220894 | 3 | – Pembrolizumab – SOC (platinum-based chemotherapy) |
PD-L1-positive, stage IIIb/IV
NSCLC – OS – PFS |
| Maintenance treatment | |||
| NCT02564380 | 2 | – Pembrolizumab – Placebo |
Stage IV squamous NSCLC after platinum-based
CT – PFS – ORR, OS, PD-L1 expression, safety, QoL |
| >First-line treatment | |||
| NCT02364609 | 1 | – Pembrolizumab + afatinib | Advanced/metastatic NSCLC with EGFR activating mutations
after PD on erlotinib – Safety and tolerability – ORR, DCR, PFS |
| NCT02475213 | 1 | – Pembrolizumab + MGA271 | Advanced solid tumors and NSCLC expressing
B7-H3 – Toxicity – PK, antitumor activity |
| NCT02443324 | 1 | – Pembrolizumab + ramucirumab | Advanced NSCLC treated with 0–3 prior lines of
therapy – DLT – ORR, DOR, TTR, PFS, OS, PK |
| NCT02451930 | 1 | – Pembrolizumab + necitumumab | Stage IV NSCLC pretreated with a previous platinum-based
CT – DLT, ORR – PK, DCR, DOR, PFS, OS |
| NCT02437136 | ½ | – Pembrolizumab + entinostat | Advanced NSCLC previously untreated and treated with
PD-1/PD-L1 antibodies – AE, ORR – CBR, PFS, OS, DOR, TTR |
| NCT02422381 | ½ | – Pembrolizumab + gemcitabine | Advanced NSCLC – Toxicity – PFS, OS, response |
| NCT02638090 | 1/2 | – Pembrolizumab – Pembrolizumab + vorinostat |
Advanced/metastatic pretreated NSCLC but immunotherapy
naïve – MTD – PFS, ORR |
| NCT02178722 | ½ | – Pembrolizumab + epacadostat | Advanced NSCLC after at least one platinum-based
CT – DLT, ORR – PFS, safety and tolerability, OS |
| NCT02501096 | ½ | – Pembrolizumab + lenvatinib | Advanced NSCLC – MTD, ORR, DLT – PFS, OS, DOR, CBR, PK |
| NCT02574598 | 2 | – Docetaxel – Docetaxel + pembrolizumab |
Advanced PD-L1+ NSCLC after 1 platinum-based
CT – ORR |
| NCT02546986 | 2 | – Pembrolizumab + placebo – Pembrolizumab + CC-486 |
Stage IIIb/IV NSCLC after 1 prior platinum-based
CT – PFS – ORR, DCR, OS, PK, AE |
| NCT02492568 | 2 | – Pembrolizumab – SBRT→pembrolizumab |
Stage IV NSCLC after at least 1 prior platinum-based
CT – ORR – DCR, PFS, OS, toxicity |
| NCT02085070 | 2 | – Pembrolizumab | Untreated brain metastasis in metastatic
NSCLC – ORR – Brain response rate |
| NCT02681549 | 2 | – Pembrolizumab + bevacizumab | Untreated brain metastasis in metastatic
NSCLC – Brain metastasis response rate – ORR, PFS, safety and toxicity |
AE, adverse event; ALK, anaplastic lymphoma kinase; CBDCA, carboplatin; CBR, clinical benefit rate; CT, chemotherapy; DLT, dose-limiting toxicities; DOR, duration of response; EGFR, epidermal growth factor receptor; irRECIST, immune-related Response Evaluation Criteria in Solid Tumors; MTD, maximum tolerated dose; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; QoL, quality of life; RECIST, Response Evaluation Criteria in Solid Tumors; RP2D, recommended phase 2 dose; SBRT, stereotactic body radiation therapy; SOC, standard of care; TTR, time to response.