Clinical Trials

Multiple early- to late-phase clinical trials have evaluated rociletinib as monotherapy and in combination with agents such as trametinib and MPDL3280A, primarily targeting EGFR-mutated, locally advanced or metastatic non-small cell lung cancer. Sponsored by pharmaceutical companies—including Clovis Oncology, Genentech, and Novartis—and academic institutions like Washington University School of Medicine, these clinical trials were ultimately terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02705339 WITHDRAWN
Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Nonsmall Cell Lung Cancer
Washington University School of Medicine
 2016-05 PHASE2
NCT02147990 TERMINATED
Non-small Cell Lung Cancer
Clovis Oncology, Inc.
 2014-06-16 PHASE2
NCT01526928 TERMINATED
Locally Advanced or Metastatic Non Small Cell Lung Cancer
Clovis Oncology, Inc.
 2012-03-27 PHASE1; PHASE2
NCT02322281 TERMINATED
Non-small Cell Lung Cancer
Clovis Oncology, Inc.
 2015-02 PHASE3
NCT02630186 TERMINATED
Non-small Cell Lung Cancer
Clovis Oncology, Inc.
 2016-02-24 PHASE1; PHASE2
NCT02186301 TERMINATED
Non-Small Cell Lung Cancer
Clovis Oncology, Inc.
 2014-11 PHASE2; PHASE3
NCT02580708 TERMINATED
Non-small Cell Lung Cancer
Clovis Oncology, Inc.
 2015-09-30 PHASE1; PHASE2
NCT02630186 Terminated
Non-small Cell Lung Cancer
Clovis Oncology Inc.|Genentech Inc.
 2016-02-24 Phase 1|Phase 2
NCT02580708 Terminated
Non-small Cell Lung Cancer
Clovis Oncology Inc.|Novartis Pharmaceuticals
 2015-09-30 Phase 1|Phase 2
NCT02147990 Terminated
Non-small Cell Lung Cancer
Clovis Oncology Inc.
 2014-06-16 Phase 2
NCT01526928 Terminated
Locally Advanced or Metastatic Non Small Cell Lung Cancer
Clovis Oncology Inc.
 2012-03-27 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2016-05-17)

Check the Rociletinib (CO-1686) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rociletinib irreversibly and selectively binds to mutant epidermal growth factor receptor (EGFR), particularly the L858R/T790M resistance mutant, thereby blocking downstream oncogenic signal transduction and inducing apoptosis in mutant EGFR-driven cancer cells. Consequently, this targeted inhibition suppresses tumor cell proliferation and growth, providing direct therapeutic relevance for patients with mutant non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.