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Clinical trial · no report yet · Phase 1/Phase 2
NCT02716116
A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer
- NCT02716116 ↗
- Completed
- Takeda
- Focused
We haven't built an HCP commentary report on NCT02716116 yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NCT02716116 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- TAK-788
- Arms
- Part 1: Dose Escalation Component · Experimental
- Part 2: Expansion Cohort 1 · Experimental
- Part 2: Expansion Cohort 2 · Experimental
- Part 2: Expansion Cohort 3 · Experimental
- Part 2: Expansion Cohort 4 · Experimental
- Part 2: Expansion Cohort 5 · Experimental
- Part 2: Expansion Cohort 6 · Experimental
- Part 2: Expansion Cohort 7 · Experimental
- Part 3: Extension Cohort · Experimental
- Enrollment
- 324
- Primary outcomes
- Part 1, Dose Escalation Component: Recommended Phase 2 Dose (RP2D) of Orally Administered TAK-788
- Part 2, Expansion Cohorts 1, 2, 4, 5 and 7: Confirmed Objective Response Rate (ORR) Assessed by the Investigator
- Part 2, Expansion Cohort 3: Intracranial ORR (iORR) Assessed by Independent Review Committee (IRC)
- Part 2, Expansion Cohort 6: Confirmed ORR Assessed by IRC
- Part 3, Extension Cohort: Confirmed ORR Assessed by IRC
- Sponsor
- Takeda
- Start
- Jun 16, 2016
- Primary completion
- Sep 29, 2026
- Results posted
- No
- Registry record
- NCT02716116 · updated Oct 28, 2026
Publications
linked from the registry- Zhou YF, Wang GX, Yang RN, Qi H, Fan YY, Li WY, Zhao GA, Hao GL, Lin F, Chen ZG. Electrophysiological consequences of acute mobocertinib exposure in isolated rat and guinea-pig hearts and transfected cell lines. Biochem Biophys Res Commun. 2025 Sep 16;780:152460. doi: 10.1016/j.bbrc.2025.152460. Epub 2025 Aug 7. PubMed 40818285
- Hanley MJ, Zhang S, Griffin R, Zhu SX, Fram RJ, Lin J, Venkatakrishnan K, Gupta N. A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [14C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants. Invest New Drugs. 2024 Aug;42(4):343-352. doi: 10.1007/s10637-024-01446-y. Epub 2024 May 24. PubMed 38789848
- Ou SI, Lin HM, Hong JL, Yin Y, Jin S, Lin J, Mehta M, Zhang P, Nguyen D, Neal JW. Comparative effectiveness of mobocertinib and standard of care in patients with NSCLC with EGFR exon 20 insertion mutations: An indirect comparison. Lung Cancer. 2023 May;179:107186. doi: 10.1016/j.lungcan.2023.107186. Epub 2023 Apr 1. PubMed 37075617
- Christopoulos P, Prawitz T, Hong JL, Lin HM, Hernandez L, Jin S, Tan M, Proskorovsky I, Lin J, Zhang P, Patel JD, Ou SI, Thomas M, Stenzinger A. Indirect comparison of mobocertinib and real-world therapies for pre-treated non-small cell lung cancer with EGFR exon 20 insertion mutations. Lung Cancer. 2023 May;179:107191. doi: 10.1016/j.lungcan.2023.107191. Epub 2023 Apr 8. PubMed 37058788
- Ou SI, Hong JL, Christopoulos P, Lin HM, Vincent S, Churchill EN, Soeda J, Kazdal D, Stenzinger A, Thomas M. Distribution and Detectability of EGFR Exon 20 Insertion Variants in NSCLC. J Thorac Oncol. 2023 Jun;18(6):744-754. doi: 10.1016/j.jtho.2023.01.086. Epub 2023 Feb 3. PubMed 36738930
- Yang JC, Zhou C, Janne PA, Ramalingam SS, Kim TM, Riely GJ, Spira AI, Piotrowska Z, Mekhail T, Garcia Campelo MR, Felip E, Bazhenova L, Jin S, Kaur M, Diderichsen PM, Gupta N, Bunn V, Lin J, N Churchill E, Mehta M, Nguyen D. Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment for EGFR exon 20 insertion-positive non-small cell lung cancer. Expert Rev Anticancer Ther. 2023 Jan;23(1):95-106. doi: 10.1080/14737140.2023.2157815. Epub 2022 Dec 28. PubMed 36537204
- Duke ES, Stapleford L, Drezner N, Amatya AK, Mishra-Kalyani PS, Shen YL, Maxfield K, Zirkelbach JF, Bi Y, Liu J, Zhang X, Wang H, Yang Y, Zheng N, Reece K, Wearne E, Glen JJ, Ojofeitimi I, Scepura B, Nair A, Bikkavilli RK, Ghosh S, Philip R, Pazdur R, Beaver JA, Singh H, Donoghue M. FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Clin Cancer Res. 2023 Feb 1;29(3):508-512. doi: 10.1158/1078-0432.CCR-22-2072. PubMed 36112541
- Zhou C, Ramalingam SS, Kim TM, Kim SW, Yang JC, Riely GJ, Mekhail T, Nguyen D, Garcia Campelo MR, Felip E, Vincent S, Jin S, Griffin C, Bunn V, Lin J, Lin HM, Mehta M, Janne PA. Treatment Outcomes and Safety of Mobocertinib in Platinum-Pretreated Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer: A Phase 1/2 Open-label Nonrandomized Clinical Trial. JAMA Oncol. 2021 Dec 1;7(12):e214761. doi: 10.1001/jamaoncol.2021.4761. Epub 2021 Dec 16. PubMed 34647988
- Han H, Li S, Chen T, Fitzgerald M, Liu S, Peng C, Tang KH, Cao S, Chouitar J, Wu J, Peng D, Deng J, Gao Z, Baker TE, Li F, Zhang H, Pan Y, Ding H, Hu H, Pyon V, Thakurdin C, Papadopoulos E, Tang S, Gonzalvez F, Chen H, Rivera VM, Brake R, Vincent S, Wong KK. Targeting HER2 Exon 20 Insertion-Mutant Lung Adenocarcinoma with a Novel Tyrosine Kinase Inhibitor Mobocertinib. Cancer Res. 2021 Oct 15;81(20):5311-5324. doi: 10.1158/0008-5472.CAN-21-1526. Epub 2021 Aug 11. PubMed 34380634
- Riely GJ, Neal JW, Camidge DR, Spira AI, Piotrowska Z, Costa DB, Tsao AS, Patel JD, Gadgeel SM, Bazhenova L, Zhu VW, West HL, Mekhail T, Gentzler RD, Nguyen D, Vincent S, Zhang S, Lin J, Bunn V, Jin S, Li S, Janne PA. Activity and Safety of Mobocertinib (TAK-788) in Previously Treated Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations from a Phase I/II Trial. Cancer Discov. 2021 Jul;11(7):1688-1699. doi: 10.1158/2159-8290.CD-20-1598. Epub 2021 Feb 25. PubMed 33632775