CLINICAL TRIALS PROFILE FOR CISPLATIN

505(b)(2) Clinical Trials for cisplatin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00003589 ↗	Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1998-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	University of Arizona	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Dosage	NCT00968799 ↗	Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study	Terminated	Cantonal Hospital of St. Gallen	N/A	2008-02-01	Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration. For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] = dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same. In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.
New Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Janssen, LP	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.

All Clinical Trials for cisplatin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001272 ↗	A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients	Completed	National Cancer Institute (NCI)	Phase 1	1991-09-01	This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.
NCT00001426 ↗	A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1995-02-03	A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
NCT00001427 ↗	A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin	Completed	National Cancer Institute (NCI)	Phase 2	1995-01-01	The objectives of this study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.
NCT00001450 ↗	Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC	Completed	National Cancer Institute (NCI)	Phase 2	1995-09-01	This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC.
NCT00001499 ↗	Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1996-03-01	2-Drug Combination Chemotherapy Followed by Radiotherapy. Paclitaxel, TAX, NSC-125973; Cisplatin, CDDP, NSC-119875; followed by chest irradiation using 4-15 MV photons.

Clinical Trial Conditions for cisplatin

Condition Name

Condition Name for cisplatin
Intervention	Trials
Head and Neck Cancer	204
Lung Cancer	177
Non-Small Cell Lung Cancer	176
Gastric Cancer	149

Condition MeSH

Condition MeSH for cisplatin
Intervention	Trials
Carcinoma	798
Lung Neoplasms	759
Carcinoma, Non-Small-Cell Lung	651
Carcinoma, Squamous Cell	465

Clinical Trial Locations for cisplatin

Trials by Country

Trials by Country for cisplatin
Location	Trials
Canada	985
Italy	893
France	770
Spain	733
United Kingdom	689

Trials by US State

Trials by US State for cisplatin
Location	Trials
New York	620
California	596
Texas	575
Pennsylvania	484
Illinois	477

Clinical Trial Progress for cisplatin

Clinical Trial Phase

Clinical Trial Phase for cisplatin
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	76
PHASE2	273

Clinical Trial Status

Clinical Trial Status for cisplatin
Clinical Trial Phase	Trials
Completed	1513
Recruiting	957
Unknown status	458

Clinical Trial Sponsors for cisplatin

Sponsor Name

Sponsor Name for cisplatin
Sponsor	Trials
National Cancer Institute (NCI)	665
Sun Yat-sen University	161
AstraZeneca	133

Sponsor Type

Sponsor Type for cisplatin
Sponsor	Trials
Other	5458
Industry	1785
NIH	680

Cisplatin Clinical Trials Update, Market Analysis, and Future Revenue Projections (2026–2036)

Last updated: July 27, 2026

Cisplatin is an established platinum chemotherapy for multiple solid tumors, with no meaningful “cisplatin-only” pipeline scale-up visible at the trial level because most clinical development is concentrated in new combinations, dosing schedules, supportive care co-therapies, and formulation or delivery approaches that target tolerability (not new therapeutic “cisplatin” molecular entities). Market growth is driven by expanding use in oncology lines of therapy and improvements in administration/supportive care, offset by generic price compression and treatment-shift risk across platinum agents.

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What is the latest clinical trials update for cisplatin (2025–2026)?

Executive snapshot

• Trial activity is broad but fragmented, centered on combination regimens (cisplatin with immunotherapy, EGFR pathway agents, anti-angiogenics, radiotherapy, and other cytotoxics), regimen optimization (weekly vs every-3-week), and toxicity-reduction strategies (antiemetics, hydration protocols, neuropathy/ototoxicity mitigation).
• Formulation and administration innovations exist, but they generally compete in the “same active drug” category rather than establishing a new cisplatin originator-to-generic dynamic.
• Enrollment for classic cisplatin indications continues, with special emphasis on:
  • head and neck squamous cell carcinoma (HNSCC), where cisplatin remains a backbone for concurrent chemoradiation
  • non-small cell lung cancer (NSCLC) in combination settings
  • urothelial carcinoma
  • ovarian and cervical cancer
  • testicular cancer

Where are cisplatin clinical trials concentrating by tumor type?

1. Head and neck cancer
   • Cisplatin-based chemoradiation optimization trials (including comparative schedules and supportive care).
2. Urothelial carcinoma
   • Cisplatin-containing regimens and maintenance or consolidation approaches when applicable.
3. NSCLC and other thoracic cancers
   • Cisplatin combinations with immune checkpoint inhibitors and anti-VEGF strategies in specific biomarker-defined or line-defined cohorts.
4. Gynecologic oncology
   • Cisplatin with radiotherapy or systemic partners in cervical cancer and ovarian cancer subsets.
5. Testicular cancer
   • High cure-rate regimens continue to be refined on tolerability and sequencing.

What trial types are most common for cisplatin right now?

• Phase 2 and Phase 3 combination studies (cisplatin plus a new systemic partner).
• Dose/schedule studies (weekly vs standard dosing).
• Supportive care studies (antiemetic regimens, hydration variations, ototoxicity mitigation strategies).
• Real-world anchored trials for adherence to supportive care protocols and toxicity outcomes.

(Public registry coverage is extensive, but “cisplatin” trials are often not powered around a new cisplatin molecular entity, so headline pipeline momentum is measured by combination program outcomes rather than “cisplatin breakthrough.”)

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Which active clinical trials are shaping cisplatin demand right now?

Executive snapshot

• Demand is influenced by trial outcomes in concurrent chemoradiation (HNSCC and cervical cancer) and by cisplatin combinations with immunotherapy in urothelial cancer and thoracic tumors.
• The highest commercial impact comes from standard-of-care reinforcement (showing non-inferiority or improved toxicity with similar efficacy), not from marginal gains that trigger payer or guideline reclassification.

Key development themes that change utilization

• Cisplatin exposure with reduced toxicity
  • Trials seeking lower rates of nephrotoxicity, ototoxicity, and severe nausea to preserve dose intensity.
• Sequencing strategies
  • Trials that clarify where cisplatin sits relative to immunotherapy or radiotherapy.
• Patient selection
  • Trials using renal function, performance status, and tumor biomarkers to identify cisplatin-eligible patients and avoid overtreatment.

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How does the cisplatin competitive landscape affect clinical development choices?

Executive snapshot

• Cisplatin is widely genericized; “cisplatin” brands compete on packaging, supply reliability, and dosing convenience, while clinical differentiation concentrates in:
  • combination evidence (new partners)
  • treatment scheduling and delivery
  • supportive care co-optimization
  • formulation that changes administration burden or tolerability

What does generic availability mean for pipeline monetization?

• For an “active ingredient” without patent exclusivity, clinical trials generally aim to:
  • establish preferred regimens and preserve guideline inclusion
  • defend reimbursement positioning via clinical outcomes rather than patent-protected formulations
  • support reimbursement for the partner drug rather than for cisplatin itself

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What patents protect cisplatin products and what does that imply for market exclusivity?

Executive snapshot

• Cisplatin has long-standing foundational IP from early eras; most regions have no broad active-ingredient exclusivity remaining.
• Market exclusivity tends to sit, if anywhere, in:
  • specific formulations
  • method-of-manufacture
  • packaging/administration devices
  • jurisdiction-specific process patents
• In practice, cisplatin market access is dominated by generic competition, with pricing constrained by tenders and formularies.

Where do remaining patent estates usually show up in cisplatin

• Formulation improvements (stabilizers, container closure, reduced administration friction).
• Specific dosing devices or preparation methods (e.g., hospital workflow advantages).
• Regimen/IP around combination indications tends to be dominated by partner drugs’ patents rather than cisplatin.

(Patent landscape effects are reflected in commercialization: cisplatin is not a “pipeline valuation” asset like a novel oncology drug; it is a “regimen and procurement” asset.)

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When does cisplatin lose exclusivity, and how does that affect pricing?

Executive snapshot

• For most markets, cisplatin active ingredient exclusivity has already expired. Any remaining protection is typically product-specific and short relative to the active ingredient category.
• Pricing is therefore controlled by:
  • generic entrants
  • procurement contracts
  • volume discounts
  • regional tender systems

What does this mean for investors

• Revenue growth for cisplatin is unlikely to come from “exclusivity duration.”
• Growth is instead tied to:
  • oncologic incidence and regimen selection
  • inclusion in standard chemoradiation pathways
  • supportive care capacity enabling dose continuity

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What is the Orange Book status of cisplatin?

Executive snapshot

• Cisplatin is extensively listed as an approved generic in the US. Most users experience market availability through multiple ANDA products rather than an originator-driven exclusivity framework.

Why Orange Book matters for cisplatin procurement

• It drives:
  • substitution at pharmacy and wholesaler levels
  • tender-based product selection
  • risk of supply interruptions across limited manufacturing sites

(Orange Book entries for cisplatin vary by label and manufacturer; a full listing requires a live Orange Book pull and is not included here.)

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How large is the cisplatin market and what are the main drivers?

Executive snapshot

• The cisplatin market remains large due to long-established utilization across multiple tumor types.
• Unit economics are constrained by generic price compression, but total revenue is supported by:
  • wide clinical use in chemoradiation and combination regimens
  • growing cancer incidence
  • large volumes in hospital infusion settings

Key demand drivers

1. Standard-of-care inclusion
   • Cisplatin remains a core platinum agent in several guideline-based regimens.
2. Dose-intensity preservation via supportive care
   • Improved antiemetic and nephroprotection protocols increase effective use.
3. Global oncology expansion
   • Incidence growth and expanded oncology capacity increase absolute demand.

Key demand headwinds

• Substitution by carboplatin and oxaliplatin in settings where they are favored for tolerability or renal risk.
• Renal impairment eligibility constraints
  • Cisplatin is often avoided in patients with reduced renal function.
• Pricing pressure
  • Tender-driven and generic-driven erosion limits growth in average selling price.

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Cisplatin market projection 2026–2036: scenario model and revenue dynamics

Executive snapshot

• Cisplatin revenue is projected to track volume growth more than price growth.
• A realistic projection framework uses:
  • global treated incidence expansion (volume)
  • stable-to-slight declining net price (price)
  • mix shift based on renal-eligibility and regimen preferences

Projection logic

• Base case
  • Moderate volume expansion with stable market share in cisplatin-favored regimens (HNSCC, cervical cancer, selected urothelial settings).
  • Net price continues a slow decline due to generic competition.
• Upside case
  • Increased cisplatin retention in standard regimens due to toxicity-reduction supportive care adoption and regimen efficacy data sustaining guideline inclusion.
• Downside case
  • Faster substitution to carboplatin/oxaliplatin in more patient groups and stronger renal-avoidance protocols in practice reduce cisplatin-eligible pool.

What growth rate should be expected

• For generic oncology injectables, base case often corresponds to low-to-mid single-digit CAGR in revenue driven by volume and utilization rather than price.
• Upside is typically capped by how much of the eligible patient population can be retained and how quickly alternatives gain share.
• Downside is typically capped by persistence of cisplatin backbone roles in chemoradiation.

(A numeric forecast requires paid market data or a cited dataset; none is provided here.)

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How does cisplatin compare with carboplatin and oxaliplatin in clinical use and market outlook?

Executive snapshot

• Carboplatin is often favored for renal tolerability.
• Oxaliplatin is dominant in colorectal cancer combinations rather than cisplatin’s chemoradiation footprint.
• Cisplatin’s comparative advantage is guideline-anchored efficacy in certain head and neck and gynecologic settings, plus specific urothelial and NSCLC combinations.

Market implications by substitution

• Where carboplatin becomes preferred due to safety profile, cisplatin utilization drops.
• Where cisplatin is maintained due to regimen efficacy or established chemoradiation standards, demand remains resilient.

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What generic entry risks exist for cisplatin?

Executive snapshot

• “Generic entry risk” is less about patent litigation and more about:
  • manufacturing capacity expansion by additional ANDA holders
  • procurement tender shifts
  • supply concentration risk if fewer manufacturers supply certain strengths/pack sizes
• The largest risk to revenue is not litigation but continued price compression.

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What manufacturing and IP barriers affect cisplatin supply reliability?

Executive snapshot

• Cisplatin manufacturing is not typically described as a barrier like a biologic facility, but it is affected by:
  • hazardous materials handling and compliance costs
  • scale economies
  • limited supplier concentration in certain geographies
• Supply interruptions impact hospital procurement continuity and can temporarily support higher pricing until normalized.

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How do clinical trial outcomes affect cisplatin procurement and guideline inclusion?

Executive snapshot

• In practice, cisplatin procurement responds to:
  • guideline changes for chemoradiation regimen choice
  • payer coverage policies tied to toxicity-management requirements
  • observed real-world feasibility of cisplatin dosing under standard supportive care protocols

Trial endpoints that most influence adoption

• Acute and cumulative nephrotoxicity rates
• Ototoxicity incidence
• Hospitalization or discontinuation due to toxicity
• Dose intensity maintenance
• Survival endpoints when driven by cisplatin combination strategy (often partner drug effect combined with cisplatin backbone)

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Key Takeaways

• Cisplatin development is dominated by combination regimens, schedule optimization, and toxicity-reduction supportive care, not by new cisplatin molecular entities.
• Market growth is best explained by volume expansion and regimen persistence, while price growth is limited by generic competition.
• The biggest determinants of future cisplatin demand are guideline inclusion in chemoradiation and patient eligibility management that sustains dosing continuity.
• Forecasting cisplatin revenue over 2026–2036 should assume low-to-mid single-digit revenue CAGR in base case driven by volume, with upside/downside driven by substitution rates to other platinums and supportive care effectiveness.

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FAQs

1. Which cancer types have the highest ongoing cisplatin trial activity?
2. Does weekly cisplatin dosing change toxicity outcomes versus standard schedules in trials?
3. How do renal function criteria affect real-world cisplatin eligibility and utilization?
4. What supportive care protocols most reduce cisplatin nephrotoxicity and ototoxicity in practice?
5. How do tender pricing and generic supply concentration influence cisplatin average selling price?

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling databases. FDA. https://www.accessdata.fda.gov
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. ClinicalTrials.gov. (n.d.). Cisplatin studies. https://clinicaltrials.gov