TUB-040 / Non Small Cell Lung Cancer · Phase 2 Trial

Study of TUB-040 in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 2 study of TUB-040, a drug candidate for unresectable or metastatic nonsquamous NSCLC. No results have been posted to the registry; the study has not yet begun recruitment. Clinicians and researchers should treat this as early-stage development with no evidence of efficacy or safety to report at this time.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. NSCLC, Non Small Cell Lung Cancer; age from 18 Years. Intervention: NSCLC Dose 1; NSCLC Dose 2. n = 80. 2 sites: United States.

Key findings

Safety

This is a registry record; no results, safety data, efficacy data, or outcome analyses are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a planned Phase 2 interventional trial with no results posted; it is in pre-recruitment stage and represents early-phase development of TUB-040 in NSCLC.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) (assessed at From enrollment until 30 days after last dose of study drug); Overall Response Rate (ORR) (assessed at Enrollment until approximately 80 days since last dose of study drug)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationNSCLC, Non Small Cell Lung Cancer; age from 18 Years

Sample size80

InterventionNSCLC Dose 1; NSCLC Dose 2

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment80

PhasePhase 2

Primary outcome 1: Treatment-emergent adverse events (TEAEs)Enrollment until 30 days after last dose

Primary outcome 2: Overall Response Rate (ORR)Enrollment until approximately 80 days since last dose

Caveats

This is a registry record; no results, safety data, efficacy data, or outcome analyses are reported.
Study has not yet begun recruitment (status: NOT_YET_RECRUITING).
No comparator arm or control group is specified in the registry text.
No detail on study design features (e.g., blinding, randomisation, dose escalation schema) is provided in this registry extract.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design with stated safety and efficacy endpoints.

Directness

strong

Direct comparison intended: safety, tolerability, PK, and effectiveness in metastatic NSCLC.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

No methods detail on blinding, randomisation, or comparator group in registry text.

Sample adequacy

limited

Planned enrollment 80 participants; modest for Phase 2 but standard for early development.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07806773). This is a study registration, not published results. Lead sponsor: Tubulis GmbH. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: NSCLC, Non Small Cell Lung Cancer. Interventions: DRUG: TUB-040. Primary outcome measures: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) , From enrollment until 30 days after last dose of study drug; Overall Response Rate (ORR) , Enrollment until approximately 80 days since last dose of study drug. Brief summary: The goal of this clinical study is to learn more about the study drug TUB-040, safety, tolerability, pharmacokinetics (PK), and effectiveness in treating patients with unresectable or metastatic non-small cell lung cancer (NSCLC). The primary objectives of this study are to determine the safety and tolerability and effectiveness of TUB-040, and/or recommended Phase 2 dose (RP2D).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

TUB-040TubulisNCT07806773Non Small Cell Lung Cancer