Clinical-trials landscape

TL;DR

• The LUSC trial landscape has moved from unselected cytotoxic comparisons to perioperative immunotherapy, biomarker-defined metabolism, antibody–drug conjugates (ADCs), personalized vaccines, ctDNA-guided treatment, and duration/de-escalation questions.
• The most important negative lesson is structural: a recurrent genomic alteration, cell-surface protein, or encouraging response rate is not enough. LUSC repeatedly defeats programs through intratumour heterogeneity, non-oncogene dependence, toxicity, or failure to improve survival.
• Trial eligibility is a clinical decision. Histology, TNM edition, measurable disease, prior checkpoint therapy, molecular alteration, brain-metastasis status, organ function, autoimmune history, bleeding risk, and washout periods all matter.
• “Recruiting” is registry status, not a promise that a nearby site has an open slot. Contact information, cohort availability, geography, and last update must be rechecked on the day of referral.
• Completed landmark trials belong in the landscape because they explain current standards; active studies belong because they expose unresolved questions. They should never be mixed in one undifferentiated list.
• All registry identifiers and statuses below were fetched live from the ClinicalTrials.gov API v2 on 31 August 2026.

How this landscape was built

The registry was searched using squamous NSCLC, lung squamous carcinoma, Lung-MAP, NFE2L2/KEAP1, FGFR, and TROP2 concepts. Candidate records were then fetched individually by identifier. Registry fields can be sponsor-entered, delayed, incomplete, or changed after the access date. Published efficacy claims are linked to PubMed separately; a registry result posting is not assumed to equal peer-reviewed validation.

Field	Interpretation rule
Overall status	Snapshot on access date; verify before referral
Phase	Development intent, not evidence quality by itself
Estimated enrollment	Planning number unless registry says actual
Primary outcome	Determines what the trial is powered or designed to answer
Histology	Read inclusion criteria; an “NSCLC” title may contain a dedicated squamous cohort or exclude it
Biomarker	Exact alteration, assay, expression threshold, and central confirmation matter
Intervention name	Mechanism hypothesis, not evidence of benefit
Country/site list	A listed site may not currently be open

Standards established by completed or maturing phase III trials

Trial	Registry state on 2026-08-31	Question answered	Practice consequence
CheckMate 017 ([NCT01642004](https://clinicaltrials.gov/study/NCT01642004){target="_blank" rel="noopener"})	Completed	Nivolumab vs docetaxel after platinum in advanced squamous NSCLC	Established checkpoint blockade in previously treated LUSC; OS HR 0.59 and grade 3–4 treatment-related toxicity 7% vs 55% ([PMID 26028407](https://pubmed.ncbi.nlm.nih.gov/26028407/){target="_blank" rel="noopener"})
KEYNOTE-407 ([NCT02775435](https://clinicaltrials.gov/study/NCT02775435){target="_blank" rel="noopener"})	Completed	Pembrolizumab plus carboplatin/taxane vs chemotherapy in first-line metastatic squamous NSCLC	Direct histology-specific standard across PD-L1 strata; five-year OS 18.4% vs 9.7% ([PMID 30280635](https://pubmed.ncbi.nlm.nih.gov/30280635/){target="_blank" rel="noopener"}; [PMID 36735893](https://pubmed.ncbi.nlm.nih.gov/36735893/){target="_blank" rel="noopener"})
CheckMate 816 ([NCT02998528](https://clinicaltrials.gov/study/NCT02998528){target="_blank" rel="noopener"})	Completed	Neoadjuvant nivolumab plus chemotherapy vs chemotherapy	Improved EFS and pCR without an adjuvant immune component ([PMID 35403841](https://pubmed.ncbi.nlm.nih.gov/35403841/){target="_blank" rel="noopener"})
KEYNOTE-671 ([NCT03425643](https://clinicaltrials.gov/study/NCT03425643){target="_blank" rel="noopener"})	Active, not recruiting	Perioperative pembrolizumab plus chemotherapy vs placebo pathway	Improved EFS and OS; cannot isolate postoperative contribution ([PMID 39288781](https://pubmed.ncbi.nlm.nih.gov/39288781/){target="_blank" rel="noopener"})
AEGEAN ([NCT03800134](https://clinicaltrials.gov/study/NCT03800134){target="_blank" rel="noopener"})	Active, not recruiting	Perioperative durvalumab plus chemotherapy	Improved EFS and pCR; efficacy analysis excluded known EGFR/ALK disease ([PMID 37870974](https://pubmed.ncbi.nlm.nih.gov/37870974/){target="_blank" rel="noopener"})
CheckMate 77T ([NCT04025879](https://clinicaltrials.gov/study/NCT04025879){target="_blank" rel="noopener"})	Active, not recruiting	Perioperative nivolumab plus chemotherapy	Improved EFS and pathological response; registry updated 26 August 2026 ([PMID 38749033](https://pubmed.ncbi.nlm.nih.gov/38749033/){target="_blank" rel="noopener"})
PACIFIC ([NCT02125461](https://clinicaltrials.gov/study/NCT02125461){target="_blank" rel="noopener"})	Completed	Durvalumab after concurrent chemoradiation for unresectable stage III NSCLC	Defined consolidation immunotherapy; five-year OS 42.9% vs 33.4% ([PMID 35108059](https://pubmed.ncbi.nlm.nih.gov/35108059/){target="_blank" rel="noopener"})
IMpower010 ([NCT02486718](https://clinicaltrials.gov/study/NCT02486718){target="_blank" rel="noopener"})	Active, not recruiting	Adjuvant atezolizumab after resection and platinum chemotherapy	DFS benefit greatest in stage II–IIIA PD-L1-positive disease; biomarker/jurisdiction conditions matter ([PMID 34555333](https://pubmed.ncbi.nlm.nih.gov/34555333/){target="_blank" rel="noopener"})
PEARLS/KEYNOTE-091 ([NCT02504372](https://clinicaltrials.gov/study/NCT02504372){target="_blank" rel="noopener"})	Completed	Adjuvant pembrolizumab vs placebo after complete resection	DFS benefit overall, not significant in the prespecified PD-L1 ≥50% analysis at interim report ([PMID 36108662](https://pubmed.ncbi.nlm.nih.gov/36108662/){target="_blank" rel="noopener"})

These trials enrolled NSCLC except where the squamous population is explicit. LUSC subgroup consistency may support treatment, but subgroup absolute benefit and toxicity are not always fully reported.

The platform-trial lesson

The original Lung-MAP master protocol was created specifically for previously treated advanced squamous lung cancer ([NCT02154490](https://clinicaltrials.gov/study/NCT02154490){target="_blank" rel="noopener"}); its registry status is completed. It matched patients to biomarker-defined substudies and allowed a non-match pathway. The platform demonstrated that nationwide molecular screening and modular substudies are feasible, while also documenting how often plausible targets fail to generate practice-changing efficacy ([PMID 25680375](https://pubmed.ncbi.nlm.nih.gov/25680375/){target="_blank" rel="noopener"}; [PMID 26408303](https://pubmed.ncbi.nlm.nih.gov/26408303/){target="_blank" rel="noopener"}).

Platform advantage	Remaining problem
One screening architecture for multiple hypotheses	Screen-positive prevalence can be too low for timely accrual
Arms can open and close without rebuilding the whole network	Control standards change during the platform's life
Tissue and outcome data become reusable infrastructure	Tissue exhaustion and assay turnaround still exclude patients
Negative substudies are informative	Publication and interpretation can overemphasize small response signals
Histology focus exposes LUSC biology	Later expansion to all NSCLC can dilute histology-specific learning

A search hit is not eligibility. Although [NCT04310007](https://clinicaltrials.gov/study/NCT04310007){target="_blank" rel="noopener"} has a generic NSCLC brief title and is Lung-MAP-related, its current record restricts eligibility to non-squamous NSCLC. It is therefore not an active LUSC option as of 31 August 2026.

Active LUSC-relevant studies by scientific question

Can maintenance be improved or shortened?

Trial	Status; planned enrollment	Design signal	Primary question	Interpretation boundary
Cabozantinib + pembrolizumab maintenance ([NCT05613413](https://clinicaltrials.gov/study/NCT05613413){target="_blank" rel="noopener"})	Recruiting; 36 estimated	Phase II pilot after platinum/taxane/pembrolizumab induction in metastatic squamous NSCLC	Median PFS	Small single-arm signal-seeking study; antiangiogenic bleeding and fistula risks matter in central LUSC
DIAL de-escalation ([NCT05255302](https://clinicaltrials.gov/study/NCT05255302){target="_blank" rel="noopener"})	Recruiting; 1,360 estimated	Phase II/III duration study after disease control with chemo-immunotherapy	18-month OS then OS	Lung-cancer-wide; asks whether maintenance exposure can be reduced, a patient-important toxicity/time question

Duration trials are unusually valuable because indefinite-treatment conventions can persist without randomized evidence. Overall survival, quality of life, immune toxicity, retreatment, cost, and time off treatment all belong in the endpoint set.

Can treatment be molecularly assigned or adapted?

Trial	Status; planned enrollment	Strategy	What would make it important
ctDNA-directed perioperative therapy ([NCT04966663](https://clinicaltrials.gov/study/NCT04966663){target="_blank" rel="noopener"})	Recruiting; 66 estimated	Phase II uses ctDNA to assign therapy in lung cancer	Demonstrating that acting on molecular residual disease improves relapse-free survival, not merely predicts it
DRP-104 in NFE2L2/KEAP1-altered NSCLC ([NCT07249372](https://clinicaltrials.gov/study/NCT07249372){target="_blank" rel="noopener"})	Recruiting; 37 estimated	Phase II glutamine-antagonist strategy; ORR primary	Directly targets an adverse, metabolically rewired genotype enriched in LUSC; needs durability and safety beyond response
Afatinib + prednisone ([NCT04497584](https://clinicaltrials.gov/study/NCT04497584){target="_blank" rel="noopener"})	Active, not recruiting; 12 actual	Phase II in previously treated advanced squamous NSCLC	Tests whether toxicity modulation can widen an older ErbB strategy; sample size makes estimates imprecise

ctDNA is already prognostic after resection, but treatment-predictive validation is the missing link ([PMID 37055640](https://pubmed.ncbi.nlm.nih.gov/37055640/){target="_blank" rel="noopener"}). NFE2L2/KEAP1 targeting is similarly rational but remains experimental; the alteration should qualify a patient for a trial, not for an unproven off-label metabolic therapy.

Can new antigen/payload combinations work in LUSC?

Trial	Status; planned enrollment	Agent class	Key LUSC issue
PANKU-Lung05 ([NCT07739199](https://clinicaltrials.gov/study/NCT07739199){target="_blank" rel="noopener"})	Not yet recruiting; 200 estimated	Phase II/III izalontamab brengitecan plus a PD-1/VEGF bispecific antibody vs carboplatin/paclitaxel plus the same bispecific antibody	Direct first-line advanced squamous population; the phase III primary endpoint is PFS, and the shared experimental bispecific in both arms means the comparison isolates the ADC-containing backbone rather than the entire regimen
HLX43 ± HLX07 vs docetaxel ([NCT07459751](https://clinicaltrials.gov/study/NCT07459751){target="_blank" rel="noopener"})	Recruiting; 706 estimated	Phase II/III ADC alone or with EGFR antibody	Direct advanced/metastatic squamous population; OS and PFS primary outcomes are stronger than response alone
HDM2020 ([NCT07638891](https://clinicaltrials.gov/study/NCT07638891){target="_blank" rel="noopener"})	Recruiting; 150 estimated	Phase I FGFR2b-directed ADC	Requires reproducible FGFR2b selection, therapeutic window, and proof that expression is sufficiently homogeneous
Enfortumab vedotin EV-202 ([NCT04225117](https://clinicaltrials.gov/study/NCT04225117){target="_blank" rel="noopener"})	Active, not recruiting; 329 actual across cohorts	Nectin-4-directed ADC, with a pembrolizumab combination in a later cohort	Basket structure means lung-histology cohort data must be separated from pan-tumour totals

ADC development cannot assume that a surface target is uniform or that payload sensitivity is histology-agnostic. TROPION-Lung01 is a warning: datopotamab deruxtecan improved PFS overall, but the squamous subgroup numerically favoured docetaxel for both PFS and OS ([PMID 39250535](https://pubmed.ncbi.nlm.nih.gov/39250535/){target="_blank" rel="noopener"}).

Can immunity be personalized or rebuilt?

Trial	Status; planned enrollment	Strategy	Central uncertainty
V940-013 ([NCT07221474](https://clinicaltrials.gov/study/NCT07221474){target="_blank" rel="noopener"})	Recruiting; 180 estimated across 11 countries listed	Personalized neoantigen vaccine intismeran autogene/placebo plus pembrolizumab and carboplatin/taxane	Manufacturing time, neoantigen quality, added benefit over a strong control, and accessibility
Cancer-specific CD8+ TIL therapy ([NCT05902520](https://clinicaltrials.gov/study/NCT05902520){target="_blank" rel="noopener"})	Active, not recruiting; 18 estimated	Phase I selected tumour-infiltrating lymphocytes with low-dose IL-2	Feasibility, lymphodepletion/IL-2 burden, antigen escape, and scalable manufacturing
PF-08634404 in early/locally advanced NSCLC ([NCT07489066](https://clinicaltrials.gov/study/NCT07489066){target="_blank" rel="noopener"})	Recruiting; 120 estimated across five countries listed	Phase II monotherapy/combination development; surgical feasibility and pCR endpoints	Mechanism must improve cure without delaying or preventing surgery

Personalization adds logistical endpoints that conventional drug trials can ignore: proportion successfully manufactured, time from biopsy to dose, dropout before infusion, representativeness of included patients, and cost per treated—not merely enrolled—participant.

Status is not evidence

Registry label	What it means	What it does not mean
Recruiting	Sponsor reports at least one recruiting site/cohort	Every listed site has capacity, the LUSC cohort is open, or the therapy works
Active, not recruiting	Intervention/follow-up continues without new enrollment	Results are mature or publicly available
Completed	Protocol-defined participation ended	Results are posted, peer reviewed, positive, or practice changing
Terminated	Study stopped early	The drug necessarily lacked efficacy; inspect reason, exposure, and data
Unknown	Status not recently verified under registry rules	Trial is definitely closed
Withdrawn	Stopped before enrollment	Biological hypothesis was disproven

Trial matching checklist

1. Confirm pathology and whether mixed/adenosquamous histology is allowed.
2. Record TNM descriptors, edition, resectability, measurable disease, and all metastatic sites.
3. Complete the molecular assay required by the trial, including exact variant and central confirmation rules.
4. Build a line-by-line treatment history: agents, dates, best response, progression pattern, and grade ≥3 toxicity.
5. Review brain metastases, steroids, autoimmune disease, transplant, interstitial lung disease, infection, and anticoagulation.
6. Check haemoptysis, cavitation, major-vessel invasion, and fistula risk for antiangiogenic or some ADC programs.
7. Verify ECOG status, renal/hepatic/marrow function, ECG, pulmonary function, and washout intervals.
8. Ask whether the control arm is a reasonable current option for this individual.
9. Verify cohort status and slot with the site; do not rely only on overall registry status.
10. Discuss travel, biopsies, blood draws, hospitalization, contraception, caregiver burden, and financial toxicity.

Endpoint literacy

Endpoint	Useful for	Vulnerability
ORR	Early antitumour activity	Can be brief; ignores stable disease, toxicity, and survival
PFS	Delaying progression/death	Scan timing, censoring, and pseudoprogression can influence it
EFS	Curative-intent multimodality sequence	Definitions include different pre/postoperative events across trials
pCR/MPR	Rapid perioperative signal	Surrogacy for OS is not perfect; pathology processing must be standardized
OS	Patient-important and hard to dispute	Requires time and is diluted by crossover/subsequent therapy
ctDNA clearance	Sensitive biological response	Assay- and shedding-dependent; treatment-guided utility unproven
PRO/QoL	Function and lived net benefit	Missing data are often informative rather than random
Feasibility	Surgery/manufacturing/delivery success	Must count all enrolled or intended patients, not only treated completers

Portfolio gaps

• LUSC-specific trials for older, frail, ECOG 2–3, COPD, autoimmune, and transplant populations remain sparse.
• Central-airway obstruction, cavitation, and bleeding risk are usually exclusions or safety variables, not primary research questions.
• Few trials randomize ctDNA-guided escalation or de-escalation.
• The marginal value of adjuvant checkpoint blockade after neoadjuvant pCR remains unisolated.
• ADC programs need prospective histology interaction and target-heterogeneity studies.
• Patient-reported breathlessness, cough, haemoptysis fear, cognition, caregiver burden, and treatment time are inconsistently prioritized.
• Global participation does not guarantee representative access within countries or among rural and lower-income patients.

Open questions

1. Can NFE2L2/KEAP1-directed metabolic therapy convert an immune-resistant state without prohibitive systemic toxicity?
2. Which surface antigen is sufficiently homogeneous and tumour-selective for a durable LUSC ADC?
3. Can MRD-guided treatment reduce recurrence and spare MRD-negative patients unnecessary therapy?
4. What is the minimum effective duration of maintenance immunotherapy after chemo-immunotherapy response?
5. Can platform trials report completed negative hypotheses as visibly as positive substudies?

Related pages

• Failed and frontier targets
• Molecular landscape
• Biomarkers
• Early-stage and perioperative therapy
• Systemic therapy

References

1. ClinicalTrials.gov. CheckMate 017. [NCT01642004](https://clinicaltrials.gov/study/NCT01642004){target="_blank" rel="noopener"}
2. ClinicalTrials.gov. KEYNOTE-407. [NCT02775435](https://clinicaltrials.gov/study/NCT02775435){target="_blank" rel="noopener"}
3. ClinicalTrials.gov. CheckMate 816. [NCT02998528](https://clinicaltrials.gov/study/NCT02998528){target="_blank" rel="noopener"}
4. ClinicalTrials.gov. KEYNOTE-671. [NCT03425643](https://clinicaltrials.gov/study/NCT03425643){target="_blank" rel="noopener"}
5. ClinicalTrials.gov. AEGEAN. [NCT03800134](https://clinicaltrials.gov/study/NCT03800134){target="_blank" rel="noopener"}
6. ClinicalTrials.gov. CheckMate 77T. [NCT04025879](https://clinicaltrials.gov/study/NCT04025879){target="_blank" rel="noopener"}
7. ClinicalTrials.gov. PACIFIC. [NCT02125461](https://clinicaltrials.gov/study/NCT02125461){target="_blank" rel="noopener"}
8. ClinicalTrials.gov. IMpower010. [NCT02486718](https://clinicaltrials.gov/study/NCT02486718){target="_blank" rel="noopener"}
9. ClinicalTrials.gov. PEARLS/KEYNOTE-091. [NCT02504372](https://clinicaltrials.gov/study/NCT02504372){target="_blank" rel="noopener"}
10. ClinicalTrials.gov. Lung-MAP master protocol. [NCT02154490](https://clinicaltrials.gov/study/NCT02154490){target="_blank" rel="noopener"}
11. ClinicalTrials.gov. Cabozantinib/nivolumab Lung-MAP-related study. [NCT04310007](https://clinicaltrials.gov/study/NCT04310007){target="_blank" rel="noopener"}
12. ClinicalTrials.gov. ctDNA-directed lung-cancer therapy. [NCT04966663](https://clinicaltrials.gov/study/NCT04966663){target="_blank" rel="noopener"}
13. ClinicalTrials.gov. Cabozantinib plus pembrolizumab maintenance. [NCT05613413](https://clinicaltrials.gov/study/NCT05613413){target="_blank" rel="noopener"}
14. ClinicalTrials.gov. V940-013 personalized vaccine study. [NCT07221474](https://clinicaltrials.gov/study/NCT07221474){target="_blank" rel="noopener"}
15. ClinicalTrials.gov. DRP-104 in NFE2L2/KEAP1-altered NSCLC. [NCT07249372](https://clinicaltrials.gov/study/NCT07249372){target="_blank" rel="noopener"}
16. ClinicalTrials.gov. HLX43 ± HLX07 in advanced squamous NSCLC. [NCT07459751](https://clinicaltrials.gov/study/NCT07459751){target="_blank" rel="noopener"}
17. ClinicalTrials.gov. PANKU-Lung05. [NCT07739199](https://clinicaltrials.gov/study/NCT07739199){target="_blank" rel="noopener"}
18. ClinicalTrials.gov. HDM2020 FGFR2b ADC. [NCT07638891](https://clinicaltrials.gov/study/NCT07638891){target="_blank" rel="noopener"}
19. ClinicalTrials.gov. DIAL maintenance-duration trial. [NCT05255302](https://clinicaltrials.gov/study/NCT05255302){target="_blank" rel="noopener"}
20. ClinicalTrials.gov. Cancer-specific CD8+ TIL therapy. [NCT05902520](https://clinicaltrials.gov/study/NCT05902520){target="_blank" rel="noopener"}
21. ClinicalTrials.gov. EV-202 enfortumab vedotin basket study. [NCT04225117](https://clinicaltrials.gov/study/NCT04225117){target="_blank" rel="noopener"}
22. ClinicalTrials.gov. Afatinib plus prednisone in squamous NSCLC. [NCT04497584](https://clinicaltrials.gov/study/NCT04497584){target="_blank" rel="noopener"}
23. ClinicalTrials.gov. Symbiotic-Lung-10. [NCT07489066](https://clinicaltrials.gov/study/NCT07489066){target="_blank" rel="noopener"}
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