Pemetrexed Disodium Hydrate in Metastatic Malignant Neoplasm to the Leptomeninges: NCT07751536 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Not Applicable
Clinical phase
Recruiting
Recruitment status
84
Planned enrollment
2028-07-31
Primary-completion proxy
Executive view
NCT07751536 evaluates Pemetrexed Disodium Hydrate in Metastatic Malignant Neoplasm to the Leptomeninges. The disclosed sponsor is Anhui Provincial Cancer Hospital, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Intracranial progression-free survival (iPFS), assessed over up to 2 years.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07751536 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Metastatic Malignant Neoplasm to the Leptomeninges landscape. Drug & Asset MCP drug_fetch was queried for Pemetrexed Disodium Hydrate, while Company & Deal Intelligence MCP organization_fetch was queried for Anhui Provincial Cancer Hospital.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07751536 | Pemetrexed Disodium Hydrate | Not Applicable / Recruiting | Anhui Provincial Cancer Hospital | China | Intracranial progression-free survival (iPFS) up to 2 years | 2028-07-31 |
| NCT07784959 | NXP-900 | Phase 1 / Recruiting | Nuvectis Pharma, Inc. | United States | Number of patients with treatment related adverse events and/or clinical laboratory abnormalities Up to 30 days post treatment | 2027-08-01 |
| NCT07782359 | Tirzepatide | Phase 1 / Not yet recruiting | The University of Chicago | United States | Body weight changes 1 year post treatment start | 2030-06-01 |
| NCT07759492 | Durvalumab | Phase 2 / Not yet recruiting | Intergroupe Francophone Cancerologie Thoracique | France | To evaluate the efficacy of a personalized strategy of consolidation immunotherapy based on the assessment of MRD post… 12 months after randomisation. | 2030-11-01 |
| NCT07761910 | Flurpiridaz F 18 | Phase 2 / Recruiting | Indiana University | United States | Change of MBF (myocardial blood flow) Pre-radiotherapy and 3 months post-radiotherapy | 2027-07-01 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07751536 is a Not Applicable, recruiting study with 84 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “Intracranial progression-free survival (iPFS)” over “up to 2 years.” The retrieved endpoint description is: Intracranial progression-free survival (iPFS) is defined as the time from enrollment to the date of intracranial progression or death from any cause, whichever occurs first.For subjects without observed intracranial progression or death, iPFS will be censored at the time of the last valid and adequate intracranial tumour assessment. iPFS analysis will be based on the Full Analysis Set (FAS). The median iPFS and its 95% CI will be estimated using the Kaplan-Meier method, and progression-free survival curves will be generated. Treatment group comparison will be performed using stratified log-rank test, and hazard….
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 84 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Pemetrexed Disodium Hydrate as control therapy. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Metastatic Malignant Neoplasm to the Leptomeninges. These records do not establish direct evidence for NCT07751536 unless the registration number matches.
A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
Phase 3; n=1415; Compare Disease Free Survival (DFS) for Patients With NSCLC That is PD-L1 Expression TC ≥ 25% and Patients Without EGFR Exon 21 L858R Mutation or Exon 19 Deletions or ALK Gene Rearrangements(Median) = 60.2 DFS time in months. (95% Confidence Interval, 47.7 - NA); Compare Disease Free Survival (DFS) for Patients With NSCLC That is PD-L1 Expression TC ≥ 25% and Patients Without EGFR Exon 21 L858R Mutation or Exon 19 D… Source: https://clinicaltrials.gov/ct2/show/results/NCT02273375
ASTRES: A Phase 2, Single-Arm Study of Atezolizumab in Locally Advanced, Unresectable, Stage III, Non-Small Cell Lung Cancer
Phase 2; n=127; PFS(IRF-assessed 12-month) = 54.9 % ( 46.0 - 63.7) Source: https://cattendee.abstractsonline.com/meeting/21487/Session/124
First-Line Chemoimmunotherapy and Chemotherapy Outcomes in RET Fusion-Positive Lung Cancer Patients in LIBRETTO-431
Phase 3; n=102; mPFS: P-Value = 0.8; mPFS = 11.0 month ( 11.0 - 17.0) Source: https://cattendee.abstractsonline.com/meeting/21487/Session/187
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Pemetrexed Disodium Hydrate is indexed as Small molecule drug with DHFR x GART x TYMS biology and a global stage of Approved. The asset profile lists Eli Lilly & Co. as an originator or developer.
Anhui Provincial Cancer Hospital is indexed in China. The organization record is used to resolve sponsor identity. The record lists 2 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Pemetrexed Disodium Hydrate is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07751536
Protocol source: https://clinicaltrials.gov/study/NCT07751536
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 September 2026.
Pemetrexed Disodium Hydrate in Metastatic Malignant Neoplasm to the Leptomeninges is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Intracranial progression-free survival (iPFS) and 2028-07-31 the leading decision points.
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