NCT01630733Phase 3Completed

A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2016-11-17Actual

Enrollment · participants664Actual

Source updated2026-04-15Last update listed in the registry record

Version history

Changes to this trial

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Posted 2026-04-15 · 6 fields changed

Primary outcomes · main study measures

Text edit · unverified significance

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measure: Overall Survival

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measure: Overall Survival: All Randomized Population; measure: Overall Survival: Stratified by Histology - Squamous vs. Non-Squamous

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Participant count type

Recorded edit

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Estimated

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Actual

Enrollment · participant count

Recorded edit

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count: 700; type: ESTIMATED

+ Updated value

count: 664; type: ACTUAL

Completion date type

Recorded edit

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Estimated

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Actual

Primary completion date

Recorded edit

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2017-07

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2016-11-17

Recruitment status

Recorded edit

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Recruiting

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Completed

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Study details

Conditions studied

Non-Small Cell Lung Cancer

Treatments or interventions studied

CustirsenDrugAlso known as OGX-011, TV-1011
DocetaxelDrug

Primary outcomes · main study measures

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measure: Overall Survival: All Randomized Population; description: Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.; timeFrame: From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm); measure: Overall Survival: Stratified by Histology - Squamous vs. Non-Squamous; description: Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.; timeFrame: From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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