Hansoh Opens Enrollment for HS-20122 Combo in EGFR-Mutant NSCLC
The Phase 1b trial moved to recruiting status with a 2028 primary completion date, entering a crowded EGFR field where Osimertinib and six other direct comparators already run late-stage studies.
Executive Summary
- NCT07645222 moved from Not yet recruiting to Recruiting on 2026-07-06, confirming Hansoh BioMedical has started dosing patients in its Phase 1b combination study of HS-20122 in NSCLC Press ReleasePress ReleaseJul 6, 2026.
- The trial shows zero protocol amendments since its first posting and an enrollment start that landed two weeks ahead of the original anticipated date, both signals of a stable early-stage launch.
- HS-20122 enters an EGFR-targeted field with 245 active trials and at least seven direct comparators already in Phase 2 or later, including Osimertinib and four EGFR-directed antibody-drug conjugates, which limits the differentiation runway for a Phase 1 entrant.
- No efficacy, safety, or dose-finding data exist yet for HS-20122 in this trial or in any prior study, so this update establishes operational status only, not clinical signal.
- The event advances the trial toward its 2028-10-31 primary completion date and carries no red flags, but it resolves nothing about whether HS-20122's combination approach can compete with an already crowded EGFR inhibitor and ADC field.
The status change
ClinicalTrials.gov registered NCT07645222 as Recruiting on 2026-07-06, updated from Not yet recruiting, according to the trial's change-status disclosure Press ReleasePress ReleaseJul 6, 2026. The Phase 1b study tests HS-20122, an EGFR inhibitor, in combination regimens for patients with locally advanced or metastatic NSCLC who are either treatment-naive or have received at least one prior line of standard-of-care therapy. The trial targets 396 patients across sites in China, with a primary completion date set for 2028-10-31 and full study completion projected for 2029-04-30.
What the registry shows
The trial's enrollment start moved to an actual date of 2026-06-15, ahead of the 2026-06-30 date anticipated when the study was first submitted on 2026-06-08. AppliedXL's protocol stability tool logged zero change events per year and rated the trial 'Stable,' the cleanest read available at this early stage. That combination, an early start and no amendment churn, points to an operationally clean launch, though it says nothing yet about whether the drug will work.
The endpoint bar
The study lists five co-primary endpoints: investigator-evaluated ORR, the recommended Phase 2 dose (RP2D) for the combination, and three adverse-event incidence measures (SAE, TEAE, TRAE), each assessed over the roughly two-year trial duration. This mix of an efficacy readout, a dose-finding output, and safety incidence data means no single number will resolve the trial; the RP2D and safety findings will determine whether a Phase 2 combination advances at all, independent of any early response signal. No results have posted to ClinicalTrials.gov for any of these measures.
The competitive field
HS-20122 enters an EGFR-targeted NSCLC landscape with 245 active trials tracked against the target and 864 active trials across the broader indication. AppliedXL's competitive framework names Osimertinib (AstraZeneca, Phase 4), BL-B01D1 (Sichuan Baili Pharmaceutical, Phase 2/3), SHR-A2009 (Suzhou Suncadia Biopharmaceuticals, Phase 3), Izalontamab Brengitecan (Bristol-Myers Squibb, Phase 3), and Telisotuzumab Adizutecan (AbbVie, Phase 2/3) as direct comparators sharing the EGFR target. Most of these programs are already in Phase 2 or Phase 3, which puts HS-20122's Phase 1b combination well behind the field on development stage.
Landscape risk
AppliedXL's landscape score for this trial sits at 53, labeled 'challenging,' placing it in a quadrant the tool describes as 'smooth so far, but landscape is treacherous'. That reflects clean trial-level execution set against thin competitive-density and historical-outcome data specific to HS-20122, alongside a measured decline in field-wide EGFR research activity (a ratio of 0.09 between recent and older trial volume). No sponsor prior terminations or historical outcomes for HS-20122 exist in the record to benchmark against.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.