Asset profile

Lorlatinib

Small molecule

Approvedregulatory verdict

Evidence outlook

Approved — Non-Small Cell Lung Cancer

Regulatory approval supersedes design-level evidence grading — the trials behind approval are preserved below as the drug's evidence history.

track record: Weak signal

How the evidence outlook works ↗

Upcoming events

(7 total)

Estimated primary-completion dates from ClinicalTrials.gov — registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 3Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2026-12-31 · NCT05059522 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2027 (1)
January 2027 (1)
Phase 2Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2027-01-01 · NCT07083687 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2028 (3)
May 2028 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-05 · NCT06378892 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

July 2028 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-07-22 · NCT07415005 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

August 2028 (1)
Phase 1/2Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2028-08-17 · NCT06007937 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2029 (1)
September 2029 (1)
Phase 2Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2029-09 · NCT07750704 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2030 (1)
March 2030 (1)
Phase 3Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2030-03 · NCT06858410 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

See the full readout calendar ↗

All registered studies

Research

Unlock the complete ClinicalTrials.gov registry

Research includes every linked study, indication filters, phase grouping and featured-trial cross-links.

Competitive landscape

Research

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