Sample benchmark sheet · Oncology
First-line metastatic NSCLC: PFS in Phase 3 trials
What published trials showed in this setting. This is precedent, not an FDA requirement.
- Indication
- Non-Small Cell Lung Cancer
- Endpoint
- Progression-free survival (PFS)
- Setting
- First line, metastatic
- Checked
- 2 November 2026
Lowest approved precedent
+4.3 months
Gain in median PFS over the control arm
KEYNOTE-024: 10.3 vs 6.0 months
The weakest result among the approved trials on this sheet. Approved precedents listed here showed median PFS gains of +4.3 months (KEYNOTE-024, 10.3 vs 6.0), +7.1 (MARIPOSA), +8.7 (FLAURA) and +8.8 (FLAURA2); CROWN's lorlatinib median was not reached. Observed precedent, not an FDA bar: FDA's NSCLC endpoints guidance says a fixed magnitude of effect that generally will support approval cannot be specified.
The trials
Each of these trials supported an FDA approval.
| Trial | Result | Sources |
|---|---|---|
| KEYNOTE-024pembrolizumab vs chemo, PD-L1≥50%, metastatic | 10.3 vs 6.0mFigures from: Paper abstract | Reck et al., NEJM 2016 |
| FLAURAosimertinib vs gefitinib/erlotinib, EGFR-mutated, metastatic | 18.9 vs 10.2mFigures from: Paper abstract | Soria et al., NEJM 2018 |
| CROWNlorlatinib vs crizotinib, ALK-positive, metastatic | NR vs 9.3mFigures from: FDA label | Shaw et al., NEJM 2020 Lorbrena FDA label |
| FLAURA2osimertinib+chemo vs osimertinib, EGFR-mutated, metastatic | 25.5 vs 16.7mFigures from: FDA label | Planchard et al., NEJM 2023 Tagrisso FDA label |
| MARIPOSAamivantamab+lazertinib vs osimertinib, EGFR-mutated, metastatic | 23.7 vs 16.6mFigures from: Paper abstract | Cho et al., NEJM 2024 |
Results are experimental arm vs control arm. m: months. NR: median not reached.
Observed range: 10.3 months to 25.5 months, median 21.3 months. Based on the 5 named trials listed. Range and median use experimental arms that reached a median, so CROWN is left out. Stage III trials such as LAURA are excluded.
The limits of this sheet
- Each trial enrolled a different group: PD-L1 ≥50%, EGFR-mutated or ALK-positive. Read each result against its own control arm.
- Control arms differ: chemotherapy, an earlier EGFR inhibitor, crizotinib or osimertinib.
- A gain in median months is not the whole effect. KEYNOTE-024's 4.3 months came with a hazard ratio of 0.50.
- CROWN's lorlatinib median was not reached, so it cannot set the lowest gain.
- The abstracts of the CROWN and FLAURA2 papers give no medians, so those figures come from the FDA labels.
- This is precedent, not a requirement. These results supported approvals in their own context, and matching a number here guarantees nothing.
- This is a selected list. Only the trials named here are counted, and other approvals in this setting are not on this sheet.
- Results across trials are not directly comparable. Populations, control arms, follow-up and response criteria differ.
FDA context
FDA's NSCLC endpoints guidance (April 2015) says PFS may support approval when the difference is of substantial magnitude, judged against toxicity, available therapy and prior treatment: fda.gov. All five listed approvals came from randomized Phase 3 trials. Note: LAURA (osimertinib after chemoradiotherapy in stage III NSCLC) reported 39.1 vs 5.6m PFS, but it enrolled a non-metastatic population and is not part of this metastatic benchmark.
Also cited on this row
How this was checked
On 2 November 2026 automated tools checked each result against the source named beside it and resolved each paper’s DOI. No clinician has reviewed this sheet. Check the source before you rely on a figure. Tell us if something looks wrong.
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