AdvanTIG-301 closed early with 63 patients, leaving its stage III NSCLC comparisons descriptive

Sixty-three patients randomised before the trial was terminated early

AdvanTIG-301 was designed as a multicentre, randomised, multiarm, open-label phase III trial in patients with unresectable stage III NSCLC who had received no previous treatment. It set out to compare progression-free survival, overall survival, objective response rate, duration of response, disease control rate, clinical benefit rate, time to death or distant metastasis, and safety across three pairings of arms: A against C, B against C, and A against B.

Termination came with 63 patients randomised, 22 to arm A, 19 to arm B and 22 to arm C. The abstract does not state the reason for stopping or the enrolment target the trial was designed around, so how far short it fell cannot be read from it. What the authors do state is the consequence: the efficacy data are for descriptive purposes only, and the three comparisons the trial set out to make were not tested.

Progression-free survival not reached in arm A, against 10.4 months in the durvalumab arm

Median progression-free survival was not reached in arm A, with a 95% CI running from 6.3 months to not estimable. Arm B recorded 15.0 months (7.4 to not estimable) and arm C, given chemoradiotherapy followed by durvalumab, 10.4 months (5.7 to not estimable). Median overall survival and median time to death or distant metastasis were not reached in any arm.

Every one of those intervals has an unbounded upper limit, and each lower bound sits below 10.4 months. Arm A’s interval starts at 6.3 months, so the range of values consistent with its own data extends well below arm C’s point estimate. The trial reports no comparison between the arms, and the authors restrict the efficacy data to descriptive purposes.

Response rates of 68.2%, 68.4% and 59.1%, on confidence intervals that overlap throughout

Objective response rates were 68.2% in arm A (95% CI 45.1 to 86.1), 68.4% in arm B (43.4 to 87.4) and 59.1% in arm C (36.4 to 79.3). All responses recorded in the trial were partial responses, with no complete responses in any arm.

The three intervals cover much the same range, and each contains the point estimates of the other two. Arm A, which added ociperlimab, recorded 68.2% against arm B’s 68.4%, two rates within a fraction of a percentage point of each other and calculated on different denominators, 22 patients against 19. Arms A and B sit above arm C on the point estimates, and with intervals this wide the trial reports no comparison that would settle whether the difference is real.

Pneumonitis in 18.2% and interstitial lung disease in 13.6% of the ociperlimab arm

Treatment-emergent adverse events occurred in every patient in the trial. Pneumonitis occurred in 18.2% of arm A (four of 22), 5.6% of arm B (one of 18) and 9.1% of arm C (two of 22). Interstitial lung disease occurred in 13.6% of arm A (three of 22), 11.1% of arm B (two of 18) and in no patient in arm C. The majority of events of each type were grade 1 or 2.

Both toxicities matter in stage III disease, because the lungs have already received radiotherapy and the reserve to absorb further injury is limited. The safety denominator for arm B is 18 rather than the 19 randomised, so one patient assigned to that arm is absent from the safety analysis, and the abstract does not say why. Grade 3 or higher treatment-related events were near-identical across the arms, at 68.2%, 66.7% and 68.2%.

“There was a trend toward improved efficacy when adding tislelizumab with or without ociperlimab to cCRT followed by tislelizumab with or without ociperlimab compared with cCRT followed by durvalumab; however, efficacy data were for descriptive purposes only.”Xing et al., Journal for ImmunoTherapy of Cancer (2026)

No unexpected safety signals, and no comparison the trial can support

The authors report that no unexpected or new safety signals were identified. On efficacy they describe a trend favouring the addition of tislelizumab, with or without ociperlimab, over chemoradiotherapy followed by durvalumab, and immediately qualify it as descriptive.

Read at face value, the trial contributes tolerability information for concurrent immunotherapy with chemoradiotherapy in stage III NSCLC, and a set of point estimates that no statistical comparison stands behind. The abstract reports no duration of response, no disease control rate and no clinical benefit rate, although all three were listed among the objectives.